Trial Outcomes & Findings for A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19 (NCT NCT04649151)

Last Updated: 2025-09-15

Results Overview

Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Solicited ARs considered causally related to injection were graded 1-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicated lower severity, and higher score indicated greater severity. Investigator reviewed if the solicited AR was recorded as an adverse event (AE) as detailed in the AE section. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the AE section.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

4328 participants

Primary outcome timeframe

7 days post-vaccination

Results posted on

2025-09-15

Participant Flow

The study included Part 1A as the Blinded Phase with participants remaining blinded until the initiation of Part 1B (open-label cross-over vaccination phase), and Parts 1C-1, 1C-2, 2, and 3 as open-label.

A per-protocol immunogenicity subset (PPIS) of randomly selected participants from study mRNA-1273-P301 (P301) (NCT04470427) aged 18-25 meeting pre-specified criteria (N=296) was used for comparison assessments of immune response. Study "Completed" and "Not Completed" data reported in the Participant Flow were collected from "Overall Study" (that is, as 1 period regardless if a booster dose was received).

Participant milestones

Participant milestones
Measure	Part 1A: mRNA-1273 100 μg Participants received at least 1 of 2 doses of 100 micrograms (μg) mRNA-1273 by intramuscular (IM) injection (Day 1 and Day 29).	Part 1A: Placebo Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 by IM injection (Day 1 and Day 29). Participants had the option to receive crossover vaccination with 100 μg mRNA-1273 in Part 1B.	Part 1C-2: mRNA-1273 50 μg Booster Dose (BD) Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under emergency use authorization (EUA), received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 3: mRNA-1273.222 50 µg Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Some participants may have received a second dose of mRNA-1273.222 50 µg at approximately 6 months after the first dose (Day 181).
Overall Study STARTED	2490	1243	155	52	388
Overall Study Part 1: 1st Injection	2486	1240	0	0	0
Overall Study Part 1: 2nd Injection	2480	1222	0	0	0
Overall Study Part 2: 1st Injection	0	0	0	52	0
Overall Study Part 2: 2nd Injection	0	0	0	50	0
Overall Study Part 3: 1 Dose	0	0	0	0	388
Overall Study Part 3: 2 Doses	0	0	0	0	335
Overall Study Safety Analysis Set	2486	1240	155	52	388
Overall Study Solicited Safety Set	2485	1240	125	52	387
Overall Study PPIS	340	0	136	46	373
Overall Study Per Protocol (PP) Set for Efficacy	2142	1044	0	0	0
Overall Study Part 2 BD	0	0	0	19	0
Overall Study PPIS SARS-CoV-2 Positive (PPIS-Pos)	0	0	0	44	372
Overall Study Part 1C-1 BD	1357	51	0	0	0
Overall Study Part 1B Crossover Vaccination	0	96	0	0	0
Overall Study Part 1C-1 PPIS-Negative (Neg)	267	0	0	0	0
Overall Study COMPLETED	1274	74	143	41	358
Overall Study NOT COMPLETED	1216	1169	12	11	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1A: mRNA-1273 100 μg Participants received at least 1 of 2 doses of 100 micrograms (μg) mRNA-1273 by intramuscular (IM) injection (Day 1 and Day 29).	Part 1A: Placebo Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 by IM injection (Day 1 and Day 29). Participants had the option to receive crossover vaccination with 100 μg mRNA-1273 in Part 1B.	Part 1C-2: mRNA-1273 50 μg Booster Dose (BD) Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under emergency use authorization (EUA), received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 3: mRNA-1273.222 50 µg Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Some participants may have received a second dose of mRNA-1273.222 50 µg at approximately 6 months after the first dose (Day 181).
Overall Study Pregnancy	0	0	0	0	3
Overall Study Physician Decision	10	0	0	1	1
Overall Study Protocol Deviation	25	3	0	0	0
Overall Study Received another COVID-19 vaccine under EUA	495	730	0	0	0
Overall Study Withdrawal by Subject	370	113	2	7	15
Overall Study Adverse Event	1	0	0	0	0
Overall Study Lost to Follow-up	256	29	10	3	6
Overall Study Other than specified	59	294	0	0	4
Overall Study Death	0	0	0	0	1

Baseline Characteristics

Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1A: mRNA-1273 100 μg n=2490 Participants Participants were randomized to receive 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=1243 Participants Participants were randomized to receive 2 doses of placebo by IM injection (Day 1 and Day 29). Participants had the option to receive crossover vaccination with 100 μg mRNA-1273 in Part 1B.	Part 1C-2: mRNA-1273 50 μg BD n=155 Participants Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single booster of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg n=52 Participants Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 3: mRNA-1273.222 50 µg n=388 Participants Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Participants may have received a second dose of mRNA-1273.222 50 µg at approximately month 6 after the first dose (Day 181).	Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg n=296 Participants Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).	Total n=4624 Participants Total of all reporting groups
Age, Customized Age Categorical Data for Participants Enrolled in Study mRNA-1273-P203 · Adolescents (12-17 years)	2490 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	1243 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	155 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	52 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	388 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	4328 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Age, Customized Age Categorical Data for Participants Enrolled in Study mRNA-1273-P203 · Adults (18-64 years)	0 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Age, Customized Age Categorical Data for Participants Enrolled in Study mRNA-1273-P301 · Adolescents (12-17 years)	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Age, Customized Age Categorical Data for Participants Enrolled in Study mRNA-1273-P301 · Adults (18-64 years)	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	296 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	296 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Sex: Female, Male Sex Data for Participants Enrolled in Study mRNA-1273-P203 · Female	1206 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	607 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	78 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	26 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	185 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	2102 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Sex: Female, Male Sex Data for Participants Enrolled in Study mRNA-1273-P203 · Male	1284 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	636 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	77 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	26 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	203 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	2226 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Sex: Female, Male Sex Data for Participants Enrolled in Study mRNA-1273-P301 · Female	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	153 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	153 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Sex: Female, Male Sex Data for Participants Enrolled in Study mRNA-1273-P301 · Male	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	143 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	143 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Ethnicity (NIH/OMB) Ethnicity Data for Participants Enrolled in Study mRNA-1273-P203 · Hispanic or Latino	280 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	152 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	37 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	14 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	367 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	850 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Ethnicity (NIH/OMB) Ethnicity Data for Participants Enrolled in Study mRNA-1273-P203 · Not Hispanic or Latino	2190 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	1079 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	116 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	36 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	21 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	3442 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Ethnicity (NIH/OMB) Ethnicity Data for Participants Enrolled in Study mRNA-1273-P203 · Unknown or Not Reported	20 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	12 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	2 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	2 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	36 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Ethnicity (NIH/OMB) Ethnicity Data for Participants Enrolled in Study mRNA-1273-P301 · Hispanic or Latino	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	78 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	78 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Ethnicity (NIH/OMB) Ethnicity Data for Participants Enrolled in Study mRNA-1273-P301 · Not Hispanic or Latino	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	216 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	216 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Ethnicity (NIH/OMB) Ethnicity Data for Participants Enrolled in Study mRNA-1273-P301 · Unknown or Not Reported	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	2 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	2 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P203 · White	2087 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	1043 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	115 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	30 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	39 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	3314 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P203 · Black or African American	83 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	42 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	23 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	18 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	126 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	292 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P203 · Asian	143 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	80 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	3 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	3 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	229 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P203 · American Indian or Alaska Native	12 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	7 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	1 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	1 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	21 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P203 · Native Hawaiian or Other Pacific Islander	3 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	3 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P203 · Multiple	118 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	50 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	9 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	3 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	180 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P203 · Other	27 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	9 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	4 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	219 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	259 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P203 · Not Reported	11 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	11 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	22 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P203 · Unknown	6 Participants n=2490 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	1 Participants n=1243 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=155 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	1 Participants n=52 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=388 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	8 Participants n=4328 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 · White	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	207 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	207 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 · Black or African American	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	29 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	29 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 · Asian	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	30 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	30 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 · American Indian or Alaska Native	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	3 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	3 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 · Native Hawaiian or Other Pacific Islander	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	2 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	2 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 · Multiple	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	14 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	14 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 · Other	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	8 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	8 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 · Not Reported	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	3 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	3 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.
Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 · Unknown	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.	0 Participants n=296 Participants • Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.

PRIMARY outcome

Timeframe: 7 days post-vaccination

Population: Solicited Safety Set included participants who received at least 1 dose of study drug and contributed any solicited AR data.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=2485 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=1240 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD n=1351 Participants Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD n=125 Participants Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection n=52 Participants Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection n=46 Participants Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD n=19 Participants Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose n=387 Participants Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Grade 3	627 Participants	59 Participants	150 Participants	9 Participants	1 Participants	3 Participants	1 Participants	25 Participants	—
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Grade 4	3 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Grade 1	586 Participants	585 Participants	627 Participants	42 Participants	25 Participants	18 Participants	7 Participants	145 Participants	—
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Grade 2	1250 Participants	293 Participants	501 Participants	48 Participants	16 Participants	9 Participants	0 Participants	62 Participants	—
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Any Solicited (Grade 1-4)	2466 Participants	938 Participants	1278 Participants	99 Participants	42 Participants	30 Participants	8 Participants	233 Participants	—

PRIMARY outcome

Timeframe: Up to 28 days post-vaccination

Population: Safety Set: participants who received at least 1 dose of study drug. As prespecified in the protocol, Part 1B was not assessed for this outcome measure. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (onset after Day 7 of dosing). An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result or other safety assessment, including one that worsened from baseline and was considered clinically significant by the Investigator was recorded as an AE. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part1/2 but were considered clinical events for efficacy in Part 3 and not AEs. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the AE section.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=2486 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=1240 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD n=1405 Participants Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD n=155 Participants Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection n=52 Participants Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection n=19 Participants Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD n=388 Participants Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Number of Participants With Unsolicited AEs	582 Participants	237 Participants	209 Participants	19 Participants	10 Participants	2 Participants	52 Participants	—	—

PRIMARY outcome

Timeframe: Day 57 Study P203/Day 57 Study P301

Population: Part 1A PPIS: randomized participants who were selected for the Immunogenicity Subset, received planned doses of study drug per schedule, complied with immunogenicity testing schedule, and had no major protocol deviations that impacted key or critical data. Participants who were seropositive at baseline were excluded from the PPIS. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Pseudovirus nAb ID50 titers were measured using pseudovirus neutralization assay (PsVNA) assay. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available (LLOQ: 18.5 arbitrary units (AU)/milliliter (mL), ULOQ: 45118 AU/mL). Antibody levels were analyzed using an analysis of covariance (ANCOVA) model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria were used for comparison assessments of immune response.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=340 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=295 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 1A Geometric Mean Value of Serum Pseudovirus Neutralizing Antibody (nAb) ID50 Titers From Study P203 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301	1401.670 titer Interval 1276.218 to 1539.453	1299.855 titer Interval 1175.38 to 1437.511	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 57 Study P203/Day 57 Study P301

Percentage of participants with seroresponse for pseudovirus nAb ID50 measured using PsVNA assay are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4\*LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ (LLOQ: 18.5 AU/mL), ULOQ: 45118 AU/mL). PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria were used for comparison assessments of immune response.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=340 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=295 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 1A Seroresponse Rate (SRR) for Serum Pseudovirus nAb ID50 in Study P203 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301	98.8 percentage of participants Interval 97.0 to 99.7	99.0 percentage of participants Interval 97.1 to 99.8	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: BD Day 29 Study P203/Day 57 Study P301

Population: Part 1C-1 PPIS-Neg: participants were baseline (pre-dose 1 of part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, received BD, and were pre-booster SARS-CoV2 negative. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Pseudovirus nAb were measured using PsVNA assay. Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10, ULOQ: 281600). PPIS P301: randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison assessments of immune response.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=264 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=294 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 1C-1 Geometric Mean Concentration (GMC) of Serum Pseudovirus nAb Against the Original Strain After the BD in Study P203 at BD Day 29 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301	7102.0 arbitrary units (AU)/mL Interval 6553.2 to 7696.8	1400.4 arbitrary units (AU)/mL Interval 1272.7 to 1541.0	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: BD Day 29 Study P203/Day 57 Study P301

Percentage of participants with seroresponse for pseudovirus nAb measured using PsVNA assay are reported. Seroresponse relative to pre-Dose 1 (baseline) at a participant level was defined as a change from below the LLOQ to equal or above 4 \* LLOQ, or at least a 4-fold-rise if baseline was equal to or above LLOQ (LLOQ: 10 AU/mL, ULOQ: 281600 AU/mL). PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison assessments of immune response.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=264 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=294 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 1C-1 SRR of Serum Pseudovirus nAb Against the Original Strain After the BD in Study P203 at BD Day 29 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301	100.0 percentage of participants Interval 98.6 to 100.0	99.3 percentage of participants Interval 97.6 to 99.9	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 29 Study P203/Day 57 Study P301

Population: Part 3 PPIS-Pos: participants received Dose 1 of mRNA-1273.222, had Day 29 antibody assessments, no major protocol deviations, did not receive off-study COVID-19 vaccination prior to Day 29, SARS-CoV-2 positive at Baseline. 'Overall number of participants analyzed' = participants evaluable for the endpoint.

Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 103 AU/mL, ULOQ: 28571 AU/mL). ANCOVA model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison of immune response.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=372 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=294 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 3 GMC of nAb Post Dose 1 mRNA 1273.222 Against Omicron BA.4/BA.5 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301	2727.8 AU/mL Interval 2558.7 to 2908.1	56.6 AU/mL Interval 52.7 to 60.8	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: BD Day 29

Population: Part 1C-2 PPIS: all randomized participants who received BD in Part 1C-2, had BD-Day 29 Ab assessment, had no major protocol deviations that impacted key or critical data, and did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=134 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 1C-2 GMC of Post-booster Pseudovirus nAb Against Ancestral Strain at BD Day 29	9433.4 AU/mL 95% Confidence Interval 8496.8 • Interval 8496.8 to 10473.3	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 57

Population: Part 2 PPIS: all randomized participants who received at least 1 dose of the planned study drug, had Ab assessment for the analysis endpoint, and had no major protocol deviations that could impact key or critical data.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=46 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 2 GMC of the Pseudovirus nAb Against Ancestral Strain at Day 57	7351.5 AU/mL 95% Confidence Interval 5621.7 • Interval 5621.7 to 9613.7	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 29 Study P203/Day 57 Study P301

Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL). ANCOVA model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison of immune response.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=371 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=295 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 3 GMC of nAb Post Dose 1 mRNA 1273.222 Against SARS-CoV-2 Ancestral Strain Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301	7603.9 AU/mL Interval 7004.6 to 8254.6	1692.3 AU/mL Interval 1543.4 to 1855.5	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 57

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=46 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 2 SRR of Pseudovirus nAb Against Ancestral Strain	91.3 percentage of participants 95% Confidence Interval 79.2 • Interval 79.2 to 97.6	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 up to Day 751

Population: Participants who received at least 1 dose of mRNA-1273 were included in the analysis. 'Overall number of participants analyzed' = participants evaluable for this endpoint. Note: Part 3 is presented for overall study for this assessment (AE section presents AEs separately for 1 dose and second dose).

SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs were identified based upon medical concepts that may be related to COVID-19 or were of interest in COVID-19 vaccine safety surveillance. MAAE was an AE that led to an unscheduled visit to a healthcare practitioner, included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and visits to healthcare practitioners external to the study site \[for example, urgent care, primary care physician\]). Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were defined as AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=2486 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=96 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD n=1408 Participants Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD n=155 Participants Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection n=52 Participants Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection n=19 Participants Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD n=388 Participants Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study Discontinuation SAEs	21 Participants	2 Participants	9 Participants	3 Participants	0 Participants	0 Participants	16 Participants	—	—
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study Discontinuation AESIs	17 Participants	0 Participants	9 Participants	1 Participants	0 Participants	0 Participants	3 Participants	—	—
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study Discontinuation MAAEs	1040 Participants	31 Participants	541 Participants	45 Participants	12 Participants	7 Participants	183 Participants	—	—
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study Discontinuation AEs Leading to Study Discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection

Population: Part 1A PP Set for Efficacy: all randomized participants who received planned doses of study drug, had no immunologic or virologic evidence of prior COVID-19, and had no major protocol deviations that impact key or critical efficacy data.

SARS-CoV-2 infection was defined in participants with negative SARS-CoV-2 status at baseline: bAb level against SARS-CoV-2 nucleocapsid protein negative at Day 1, that became positive postbaseline; or positive postbaseline.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=2142 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=1044 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 1A Number of Participants With a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)	22 Participants	25 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection

Asymptomatic SARS-CoV-2 infection was defined as absence of symptoms and a positive RT-PCR or serology test (bAb levels against SARS-CoV-2 nucleocapsid protein) post dosing in participants who did not have an infection at baseline or pre-Dose 1.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=2142 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=1044 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 1A Number of Participants With Asymptomatic SARS-CoV-2 Infection	20 Participants	16 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 43 (14 days after second injection) up to 2.5 months after second injection

COVID-19 was defined as symptomatic disease based on the following criteria: participants experienced at least 2 of the following systemic symptoms: fever (≥ 38ºC/≥ 100.4ºF), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s); or experienced at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia; and had at least 1 nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS-CoV-2.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=2142 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=1044 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 1A Number of Participants With a First Occurrence of Symptomatic COVID-19	0 Participants	6 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection

Secondary case definition of COVID-19 was defined by the following criteria: 1 systemic or respiratory symptoms: fever (temperature \> 38ºC/≥ 100.4ºF), or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle aches, or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, or vomiting or diarrhea, and at least one positive test for SARS-CoV-2.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=2142 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=1044 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 1A Number of Participants With Secondary Case Definition of COVID-19 (Center for Disease Control and Prevention [CDC] Case Definition)	2 Participants	9 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: BD Day 29

Population: Part 1C-1 PPIS: participants were baseline (pre-dose 1 of Part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, and received BD. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Percentage of participants with seroresponse for bAb measured using (MesoScale Discovery) MSD are reported. Seroresponse from baseline (pre-Dose 1) at a participant level was defined as a change from below the LLOQ to equal or above 4 \* LLOQ, or at least a 4-fold-rise if baseline (pre-Dose 1) is equal to or above the LLOQ.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=324 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 1C-1 SRR of the Post-booster Serum Binding Antibody (bAb) Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD B.1.1.7	100.0 Percentage of participants 95% Confidence Interval 98.9 • Interval 98.9 to 100.0	—	—	—	—	—	—	—	—
Part 1C-1 SRR of the Post-booster Serum Binding Antibody (bAb) Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD B.1.351	100.0 Percentage of participants 95% Confidence Interval 98.9 • Interval 98.9 to 100.0	—	—	—	—	—	—	—	—
Part 1C-1 SRR of the Post-booster Serum Binding Antibody (bAb) Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD B.1.617.2	100.0 Percentage of participants 95% Confidence Interval 98.9 • Interval 98.9 to 100.0	—	—	—	—	—	—	—	—
Part 1C-1 SRR of the Post-booster Serum Binding Antibody (bAb) Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD P.1	100.0 Percentage of participants 95% Confidence Interval 98.9 • Interval 98.9 to 100.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: BD Day 29

Population: Part 1C-1 PPIS: participants were baseline (pre-dose 1 of Part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, and received BD. Overall number of participants analyzed' = participants evaluable for this endpoint.

Post-booster Pseudovirus nAb against B.1.1.529 (LLOQ: 8 AU/mL, ULOQ: 24503 AU/mL). Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=331 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 1C-1 GMC of Post-booster Pseudovirus nAb Against Variant Strain (B.1.1.529)	943.4 AU/mL 95% Confidence Interval 853.5 • Interval 853.5 to 1042.8	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 29 Study P203/Day 57 Study P301

Seroresponse from pre Dose 1 Baseline at a participant level was defined as a change from below the LLOQ to equal or above 4 \* LLOQ, or at least a 4-fold rise if Baseline was equal to or above the LLOQ (LLOQ: 103 AU/mL, ULOQ: 28571 AU/mL). PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison of immune response.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=372 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=294 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 3 SRR of Serum Pseudovirus nAb Post Dose 1 of mRNA-1273.222 Against Omicron BA.4/BA.5 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301	95.4 percentage of participants Interval 92.8 to 97.3	0.0 percentage of participants Interval 0.0 to 1.2	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 29 P203/Day 57 P301

Population: Part 3 PPIS-Pos: participants who received Dose 1 of mRNA-1273.222, had Day 29 antibody assessments, no major protocol deviations, did not receive off-study COVID-19 vaccination prior to Day 29, and were SARS-CoV-2 positive at baseline. 'Overall number of participants analyzed' = participants evaluable for the endpoint.

Percentage of participants with seroresponse for pseudovirus nAb measured using PsVNA assay are reported. Seroresponse from pre Dose 1 Baseline at a participant level was defined as a change from below the LLOQ to equal or above 4 \* LLOQ, or at least a 4-fold rise if Baseline was equal to or above the LLOQ. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison assessments of immune response.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=370 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=295 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 3 Pseudovirus nAb SRR of Post Dose 1 of mRNA-1273.222 Against Ancestral Strain Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301	94.9 percentage of participants Interval 92.1 to 96.9	99.3 percentage of participants Interval 97.6 to 99.9	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 29

Population: Part 3 PPIS: all participants who received Dose 1 of mRNA-1273.222 and had both Baseline (pre Dose 1) and Day 29 antibody assessment, had no major protocol deviations that impacted key or critical data; and had not received off-study COVID-19 vaccination prior to Day 29. 'Overall number of participants analyzed' = participants evaluable for the endpoint.

mRNA-1273.222 bAb was measured using a S-binding IgG immunoassay. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ are replaced by the ULOQ if actual values are not available (LLOQ: 397 AU/ml, ULOQ: 2200000 AU/mL).

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=372 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 3 GM Value of Post Dose 1 (Day 29) of mRNA-1273.222 bAb Against Other Variants of Interest BA.5	282734.2 AU/mL Interval 266581.0 to 299866.1	—	—	—	—	—	—	—	—
Part 3 GM Value of Post Dose 1 (Day 29) of mRNA-1273.222 bAb Against Other Variants of Interest AY.4	557963.4 AU/mL Interval 529270.6 to 588211.6	—	—	—	—	—	—	—	—
Part 3 GM Value of Post Dose 1 (Day 29) of mRNA-1273.222 bAb Against Other Variants of Interest B.1.1.7	434879.0 AU/mL Interval 412699.2 to 458250.8	—	—	—	—	—	—	—	—
Part 3 GM Value of Post Dose 1 (Day 29) of mRNA-1273.222 bAb Against Other Variants of Interest B.1.351	431476.5 AU/mL Interval 409656.1 to 454459.1	—	—	—	—	—	—	—	—
Part 3 GM Value of Post Dose 1 (Day 29) of mRNA-1273.222 bAb Against Other Variants of Interest B.1.1.529	189826.0 AU/mL Interval 178578.0 to 201782.5	—	—	—	—	—	—	—	—
Part 3 GM Value of Post Dose 1 (Day 29) of mRNA-1273.222 bAb Against Other Variants of Interest P.1	471868.9 AU/mL Interval 446431.3 to 498756.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 29

Population: As a result of emergence of a more divergent variant of concern (Omicron), Part 1C-2 enrollment and booster dosing were discontinued. Therefore, data were collected for Part 1C-2 Primary Outcome Measure but after Part 1C-2 was discontinued, per Sponsor, it was decided that data would not be collected for this Part 1C-2 Secondary Outcome Measure and instead collect data for the more updated variant containing vaccine (Part 3: mRNA-1273.222).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 57, 209, 394

Population: Part 1A PPIS for long term analysis included all randomized participants who had a negative SARS-CoV-2 status at baseline (pre-Dose 1), received planned doses of study drug per schedule, complied with immunogenicity testing schedule, and had no major protocol deviations that impacted key or critical data. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

SARS-CoV-2 Spike Protein-specific bAb were measured using MSD electrochemiluminescence multiplex assay. Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ are replaced by the ULOQ if actual values are not available (LLOQ: 69 AU/mL, ULOQ: 14400000 AU/mL).

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=369 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 1A GM Level of SARS-CoV-2 Spike Protein-specific bAb at Days 1, 57, 209, 394 Day 1	65.848 AU/mL Interval 60.348 to 71.85	—	—	—	—	—	—	—	—
Part 1A GM Level of SARS-CoV-2 Spike Protein-specific bAb at Days 1, 57, 209, 394 Day 57	346830.736 AU/mL Interval 330758.387 to 363684.079	—	—	—	—	—	—	—	—
Part 1A GM Level of SARS-CoV-2 Spike Protein-specific bAb at Days 1, 57, 209, 394 Day 209	79624.290 AU/mL Interval 73959.321 to 85723.172	—	—	—	—	—	—	—	—
Part 1A GM Level of SARS-CoV-2 Spike Protein-specific bAb at Days 1, 57, 209, 394 Day 394	58647.246 AU/mL Interval 52309.921 to 65752.336	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 1, 57, 209, 394

SARS-CoV-2-Specific nAb were measured using PsVNA assay. Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ are replaced by the ULOQ if actual values are not available (LLOQ: 10 AU/mL, ULOQ: 281600 AU/mL).

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=369 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 1A GM Value of SARS-CoV-2-Specific nAb at Days 1, 57, 209, 394 Day 1	11.249 AU/mL Interval 10.712 to 11.812	—	—	—	—	—	—	—	—
Part 1A GM Value of SARS-CoV-2-Specific nAb at Days 1, 57, 209, 394 Day 57	1868.363 AU/mL Interval 1758.809 to 1984.742	—	—	—	—	—	—	—	—
Part 1A GM Value of SARS-CoV-2-Specific nAb at Days 1, 57, 209, 394 Day 209	625.363 AU/mL Interval 583.319 to 670.437	—	—	—	—	—	—	—	—
Part 1A GM Value of SARS-CoV-2-Specific nAb at Days 1, 57, 209, 394 Day 394	550.262 AU/mL Interval 489.875 to 618.093	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: BD Day 29

Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. B.1.1.7 (LLOQ: 52, ULOQ: 8800000), B.1.351 (LLOQ: 111, ULOQ: 5000000), B.1.617.2 (LLOQ: 49, ULOQ: 7400000), P.1 (LLOQ: 143, ULOQ: 5800000).

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=324 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Part 1C-1 GM Value of Post-booster Dose Serum bAb Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD P.1	417277.2 AU/mL 95% Confidence Interval 391682.5 • Interval 391682.5 to 444544.5	—	—	—	—	—	—	—	—
Part 1C-1 GM Value of Post-booster Dose Serum bAb Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD B.1.1.7	581097.8 AU/mL 95% Confidence Interval 543987.7 • Interval 543987.7 to 620739.5	—	—	—	—	—	—	—	—
Part 1C-1 GM Value of Post-booster Dose Serum bAb Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD B.1.351	431569.2 AU/mL 95% Confidence Interval 404983.2 • Interval 404983.2 to 459900.6	—	—	—	—	—	—	—	—
Part 1C-1 GM Value of Post-booster Dose Serum bAb Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD B.1.617.2	456423.3 AU/mL 95% Confidence Interval 429083.9 • Interval 429083.9 to 485504.8	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Day 751

Population: Safety Set: participants who received at least 1 dose of study drug.

A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable and/or the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause.

Outcome measures

Outcome measures
Measure	Part 1A: mRNA-1273 100 μg n=2486 Participants Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=1240 Participants Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).	Part 1C-1: mRNA-1273 50 µg BD n=96 Participants Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.	Part 1C-2: mRNA-1273 50 μg BD n=1408 Participants Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg First Injection n=155 Participants Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).	Part 2: mRNA-1273 50 μg Second Injection n=52 Participants Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).	Part 2: mRNA-1273 50 μg BD n=19 Participants Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA-1273.222 50 μg 1 Dose n=388 Participants Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose n=335 Participants Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Number of Deaths Related to Study Drug Deaths	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Deaths Related to Study Drug Deaths related to study drug	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Part 1A: mRNA-1273 100 μg

Serious events: 21 serious events

Other events: 943 other events

Deaths: 0 deaths

Part 1A: Placebo

Serious events: 4 serious events

Other events: 155 other events

Deaths: 0 deaths

Part 1B: mRNA-1273 100 µg

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Part 1C-1: mRNA-1273 50 µg BD

Serious events: 9 serious events

Other events: 429 other events

Deaths: 0 deaths

Part 1C-2: mRNA-1273 50 μg BD

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

Part 2: mRNA-1273 50 μg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Part 2: mRNA-1273 50 ug BD

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part 3: mRNA1273.222 50 µg 1 Dose

Serious events: 12 serious events

Other events: 77 other events

Deaths: 0 deaths

Part 3: mRNA-1273.222 50 ug Second Dose

Serious events: 4 serious events

Other events: 51 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Part 1A: mRNA-1273 100 μg n=2486 participants at risk Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=1240 participants at risk Participants received at least 1 of 2 doses of placebo by IM injection (Day 1 and Day 29).	Part 1B: mRNA-1273 100 µg n=96 participants at risk Participants previously received 2 doses of placebo in the blinded phase and then received crossover vaccination with 100 μg of mRNA-1273.	Part 1C-1: mRNA-1273 50 µg BD n=1408 participants at risk Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1C-1.	Part 1C-2: mRNA-1273 50 μg BD n=155 participants at risk Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single booster of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg n=52 participants at risk Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 2: mRNA-1273 50 ug BD n=19 participants at risk Participants received open-label mRNA-1273 50 µg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA1273.222 50 µg 1 Dose n=388 participants at risk Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose n=335 participants at risk Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Hepatobiliary disorders Drug-induced liver injury	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Congenital, familial and genetic disorders Pectus excavatum	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Congenital, familial and genetic disorders Syringomyelia	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Congenital, familial and genetic disorders Arnold-Chiari malformation	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.30% 1/335 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Hepatobiliary disorders Hyperbilirubinaemia neonatal	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.26% 1/388 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Gastrointestinal disorders Vomiting	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Gastrointestinal disorders Diarrhoea	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Immune system disorders Anaphylactic reaction	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.65% 1/155 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations Amoebic dysentery	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.26% 1/388 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations Murine typhus	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations Dengue fever	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.3% 5/388 • Number of events 5 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations Cellulitis	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.26% 1/388 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations Appendicitis	0.08% 2/2486 • Number of events 2 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.08% 1/1240 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.07% 1/1408 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations Pneumonia	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.26% 1/388 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Injury, poisoning and procedural complications Clavicle fracture	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Injury, poisoning and procedural complications Concussion	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.07% 1/1408 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations Peritonitis	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.30% 1/335 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.30% 1/335 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Injury, poisoning and procedural complications Post procedural fever	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Injury, poisoning and procedural complications Femur fracture	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Injury, poisoning and procedural complications Facial bones fracture	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.0% 1/96 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Injury, poisoning and procedural complications Sunburn	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Injury, poisoning and procedural complications Splenic injury	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Injury, poisoning and procedural complications Vulvovaginal injury	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.07% 1/1408 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Investigations Hepatic enzyme increased	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.07% 1/1408 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.07% 1/1408 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.30% 1/335 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Metabolism and nutrition disorders Dehydration	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.07% 1/1408 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.26% 1/388 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.30% 1/335 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.30% 1/335 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Pregnancy, puerperium and perinatal conditions Abortion	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.26% 1/388 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Nervous system disorders Status migrainosus	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.07% 1/1408 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Nervous system disorders Seizure	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.65% 1/155 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Nervous system disorders Idiopathic generalised epilepsy	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Nervous system disorders Epilepsy	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.08% 1/1240 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Psychiatric disorders Depression	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.07% 1/1408 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.26% 1/388 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.60% 2/335 • Number of events 2 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Psychiatric disorders Depression suicidal	0.04% 1/2486 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Psychiatric disorders Emotional distress	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.07% 1/1408 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Psychiatric disorders Major depression	0.08% 2/2486 • Number of events 2 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Psychiatric disorders Suicidal ideation	0.20% 5/2486 • Number of events 5 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.0% 1/96 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.14% 2/1408 • Number of events 2 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Psychiatric disorders Suicide attempt	0.12% 3/2486 • Number of events 3 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.08% 1/1240 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.07% 1/1408 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Renal and urinary disorders Nephrolithiasis	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.65% 1/155 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.30% 1/335 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Renal and urinary disorders Chronic kidney disease	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.30% 1/335 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Vascular disorders Hypertension	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.26% 1/388 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.30% 1/335 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Renal and urinary disorders Obstructive nephropathy	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.08% 1/1240 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Reproductive system and breast disorders Vaginal haematoma	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.07% 1/1408 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Blood and lymphatic system disorders Hypercoagulation	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.26% 1/388 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Cardiac disorders Cardiogenic shock	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.26% 1/388 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.

Other adverse events

Other adverse events
Measure	Part 1A: mRNA-1273 100 μg n=2486 participants at risk Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 1A: Placebo n=1240 participants at risk Participants received at least 1 of 2 doses of placebo by IM injection (Day 1 and Day 29).	Part 1B: mRNA-1273 100 µg n=96 participants at risk Participants previously received 2 doses of placebo in the blinded phase and then received crossover vaccination with 100 μg of mRNA-1273.	Part 1C-1: mRNA-1273 50 µg BD n=1408 participants at risk Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1C-1.	Part 1C-2: mRNA-1273 50 μg BD n=155 participants at risk Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single booster of 50 μg mRNA-1273 IM injection on BD Day 1.	Part 2: mRNA-1273 50 μg n=52 participants at risk Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).	Part 2: mRNA-1273 50 ug BD n=19 participants at risk Participants received open-label mRNA-1273 50 µg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	Part 3: mRNA1273.222 50 µg 1 Dose n=388 participants at risk Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1).	Part 3: mRNA-1273.222 50 ug Second Dose n=335 participants at risk Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).
Gastrointestinal disorders Abdominal pain	0.32% 8/2486 • Number of events 9 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.24% 3/1240 • Number of events 3 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.43% 6/1408 • Number of events 6 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	5.3% 1/19 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.26% 1/388 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.30% 1/335 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
General disorders Injection site lymphadenopathy	5.5% 137/2486 • Number of events 146 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.48% 6/1240 • Number of events 6 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.36% 5/1408 • Number of events 5 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.9% 1/52 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations Respiratory tract infection	0.44% 11/2486 • Number of events 12 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.32% 4/1240 • Number of events 4 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.14% 2/1408 • Number of events 2 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.65% 1/155 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	6.7% 26/388 • Number of events 34 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	6.6% 22/335 • Number of events 30 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations Parainfluenzae virus infection	0.12% 3/2486 • Number of events 3 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.0% 1/96 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.14% 2/1408 • Number of events 2 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.65% 1/155 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	5.3% 1/19 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.26% 1/388 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations Nasopharyngitis	2.4% 60/2486 • Number of events 64 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.48% 6/1240 • Number of events 6 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	4.2% 4/96 • Number of events 4 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.1% 16/1408 • Number of events 17 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	7.7% 30/388 • Number of events 34 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	6.9% 23/335 • Number of events 26 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations Influenza	0.76% 19/2486 • Number of events 20 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.0% 1/96 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	2.1% 30/1408 • Number of events 30 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	4.5% 7/155 • Number of events 8 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.9% 1/52 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	10.5% 2/19 • Number of events 2 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.3% 5/388 • Number of events 6 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations COVID-19	15.4% 382/2486 • Number of events 383 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	2.7% 34/1240 • Number of events 35 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	11.5% 11/96 • Number of events 11 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	18.3% 257/1408 • Number of events 267 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	6.5% 10/155 • Number of events 10 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	5.8% 3/52 • Number of events 3 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	15.8% 3/19 • Number of events 3 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations Asymptomatic COVID-19	3.3% 81/2486 • Number of events 82 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	2.0% 25/1240 • Number of events 25 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	6.2% 6/96 • Number of events 6 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	2.8% 39/1408 • Number of events 39 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.3% 2/155 • Number of events 2 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	3.8% 2/52 • Number of events 2 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Skin and subcutaneous tissue disorders Mechanical urticaria	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	5.3% 1/19 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Psychiatric disorders Attention deficit hyperactivity disorder	1.6% 41/2486 • Number of events 41 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.48% 6/1240 • Number of events 6 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.99% 14/1408 • Number of events 14 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.3% 2/155 • Number of events 2 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	5.8% 3/52 • Number of events 3 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Psychiatric disorders Anxiety	2.3% 58/2486 • Number of events 60 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.24% 3/1240 • Number of events 3 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.0% 1/96 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.8% 26/1408 • Number of events 27 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.65% 1/155 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	5.3% 1/19 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.30% 1/335 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Nervous system disorders Headache	4.7% 117/2486 • Number of events 129 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	4.1% 51/1240 • Number of events 57 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.0% 1/96 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	2.0% 28/1408 • Number of events 29 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.65% 1/155 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.9% 1/52 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/19 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	5.2% 20/388 • Number of events 27 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.5% 5/335 • Number of events 5 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations Upper respiratory tract infection	10.3% 257/2486 • Number of events 293 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	2.3% 28/1240 • Number of events 32 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	3.1% 3/96 • Number of events 3 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	5.8% 81/1408 • Number of events 101 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	3.9% 6/155 • Number of events 8 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	3.8% 2/52 • Number of events 2 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	5.3% 1/19 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	1.0% 4/388 • Number of events 4 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Infections and infestations Tooth abscess	0.08% 2/2486 • Number of events 2 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.07% 1/1408 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	5.3% 1/19 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.30% 1/335 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Skin and subcutaneous tissue disorders Parapsoriasis	0.00% 0/2486 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1240 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/96 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/1408 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/155 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/52 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	5.3% 1/19 • Number of events 1 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/388 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.	0.00% 0/335 • Day 1 up to Day 751 All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.

Additional Information

Moderna WeCare Team

ModernaTX, Inc.

Phone: +1-866-663-3762

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place