Trial Outcomes & Findings for Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization (NCT NCT00508742)

Last Updated: 2013-05-10

Results Overview

A new acquisition was defined as the detection of a serotype (here 6A' \[6A + 6C\] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1866 participants

Primary outcome timeframe

Month 7 through Month 24

Results posted on

2013-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).	7vPnC 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Period 1: Infant Series STARTED	932	934
Period 1: Infant Series Vaccinated Dose 1 (at 2 Months of Age)	930	933
Period 1: Infant Series Vaccinated Dose 2 (at 4 Months of Age)	904	902
Period 1: Infant Series Vaccinated Dose 3 (at 6 Months of Age)	898	892
Period 1: Infant Series COMPLETED	890	889
Period 1: Infant Series NOT COMPLETED	42	45
Period 2: After Infant Series STARTED	890	889
Period 2: After Infant Series COMPLETED	883	878
Period 2: After Infant Series NOT COMPLETED	7	11
Period 3: Toddler Dose STARTED	883	878
Period 3: Toddler Dose COMPLETED	858	863
Period 3: Toddler Dose NOT COMPLETED	25	15

Reasons for withdrawal

Reasons for withdrawal
Measure	13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).	7vPnC 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Period 1: Infant Series Adverse Event	5	4
Period 1: Infant Series Protocol Violation	1	0
Period 1: Infant Series Parent/Legal Guardian Request	31	40
Period 1: Infant Series Physician Decision	1	0
Period 1: Infant Series Other	4	1
Period 2: After Infant Series Adverse Event	2	6
Period 2: After Infant Series Lost to Follow-up	1	1
Period 2: After Infant Series Protocol Violation	1	0
Period 2: After Infant Series Parent/Legal Guardian Request	0	3
Period 2: After Infant Series Failed to Return	1	0
Period 2: After Infant Series Other	2	1
Period 3: Toddler Dose Adverse Event	1	0
Period 3: Toddler Dose Lost to Follow-up	2	3
Period 3: Toddler Dose Parent/Legal Guardian Request	17	8
Period 3: Toddler Dose Other	5	4

Baseline Characteristics

Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	13vPnC n=932 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).	7vPnC n=934 Participants 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).	Total n=1866 Participants Total of all reporting groups
Age Continuous	2.2 years STANDARD_DEVIATION 0.3 • n=5 Participants	2.2 years STANDARD_DEVIATION 0.3 • n=7 Participants	2.2 years STANDARD_DEVIATION 0.3 • n=5 Participants
Sex: Female, Male Female	474 Participants n=5 Participants	471 Participants n=7 Participants	945 Participants n=5 Participants
Sex: Female, Male Male	458 Participants n=5 Participants	463 Participants n=7 Participants	921 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 7 through Month 24

Population: Evaluable culture population included all participants who adhered to protocol requirements; received the treatment to which they were randomized; had at least 1 nasopharyngeal swab for the proposed analysis and no major protocol violations.

Outcome measures

Outcome measures
Measure	13vPnC n=881 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).	7vPnC n=873 Participants 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age	20.0 percentage of participants Interval 17.4 to 22.8	36.0 percentage of participants Interval 32.8 to 39.3

SECONDARY outcome

Timeframe: Month 7, 12, 13, 18, 24

Population: Evaluable culture population; 'n' is number of participants with at least 1 determinate nasopharyngeal culture result for given serotype combination at specified time points for each arm group respectively.

Outcome measures

Outcome measures
Measure	13vPnC n=881 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).	7vPnC n=873 Participants 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age Month 7 (n= 881, 871)	7.3 percentage of participants Interval 5.6 to 9.2	10.9 percentage of participants Interval 8.9 to 13.2
Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age Month 12 (n= 881, 873)	8.1 percentage of participants Interval 6.3 to 10.1	13.7 percentage of participants Interval 11.5 to 16.2
Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age Month 13 (n= 871, 870)	5.4 percentage of participants Interval 4.0 to 7.1	13.6 percentage of participants Interval 11.4 to 16.0
Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age Month 18 (n= 864, 864)	7.1 percentage of participants Interval 5.4 to 9.0	13.5 percentage of participants Interval 11.3 to 16.0
Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age Month 24 (n= 855, 856)	6.2 percentage of participants Interval 4.7 to 8.0	10.7 percentage of participants Interval 8.8 to 13.0

Adverse Events

Infant Series 13vPnC

Serious events: 64 serious events

Other events: 454 other events

Deaths: 0 deaths

Infant Series 7vPnC

Serious events: 57 serious events

Other events: 433 other events

Deaths: 0 deaths

After Infant Series 13vPnC

Serious events: 48 serious events

Other events: 290 other events

Deaths: 0 deaths

After Infant Series 7vPnC

Serious events: 64 serious events

Other events: 324 other events

Deaths: 0 deaths

Toddler Dose 13vPnC

Serious events: 15 serious events

Other events: 238 other events

Deaths: 0 deaths

Toddler Dose 7vPnC

Serious events: 23 serious events

Other events: 240 other events

Deaths: 0 deaths

After Toddler Dose 13vPnC

Serious events: 91 serious events

Other events: 462 other events

Deaths: 0 deaths

After Toddler Dose 7vPnC

Serious events: 73 serious events

Other events: 455 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infant Series 13vPnC n=930 participants at risk Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.	Infant Series 7vPnC n=933 participants at risk Participants who received 7vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.	After Infant Series 13vPnC n=929 participants at risk Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.	After Infant Series 7vPnC n=931 participants at risk Participants who received 7vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.	Toddler Dose 13vPnC n=882 participants at risk Participants who received 13vPnC 0.5 mL intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.	Toddler Dose 7vPnC n=875 participants at risk Participants who received 7vPnC 0.5 mL dose intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.	After Toddler Dose 13vPnC n=882 participants at risk Participants who received 13vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.	After Toddler Dose 7vPnC n=875 participants at risk Participants who received 7vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.
Blood and lymphatic system disorders Leukocytosis	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Blood and lymphatic system disorders Neutropenia	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Blood and lymphatic system disorders Anaemia	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Cardiac disorders Cardiac failure congestive	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Cardiac disorders Cyanosis	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Congenital, familial and genetic disorders Ventricular septal defect	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Eye disorders Eye movement disorder	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Eye disorders Conjunctivitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Eye disorders Corneal perforation	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Diarrhoea	0.32% 3/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.22% 2/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Haematemesis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Intussusception	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Oral disorder	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Vomiting	0.22% 2/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.54% 5/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.22% 2/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.46% 4/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.6% 14/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.80% 7/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.45% 4/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Stomatitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Abdominal pain	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
General disorders Irritability	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
General disorders Pyrexia	0.86% 8/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.43% 4/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.65% 6/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.43% 4/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.46% 4/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.2% 11/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.1% 10/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
General disorders Sudden death	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
General disorders Gait disturbance	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Hepatobiliary disorders Hepatomegaly	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Immune system disorders Milk allergy	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Anal abscess	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Bacteraemia	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Bronchiolitis	1.1% 10/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.86% 8/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.43% 4/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Bronchitis	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Bronchitis viral	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Croup infectious	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Dysentery	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.45% 4/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Gastroenteritis	1.2% 11/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.86% 8/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.3% 12/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.4% 13/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.46% 4/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.5% 13/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.6% 14/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Lower respiratory tract infection	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.43% 4/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.54% 5/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.43% 4/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Meningitis aseptic	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Meningitis viral	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Meningococcal infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Otitis media	0.32% 3/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.54% 5/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.97% 9/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.1% 10/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.5% 13/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.3% 11/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Otitis media acute	0.22% 2/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Pertussis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Pharyngitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Pneumonia	0.22% 2/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.54% 5/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.75% 7/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.0% 9/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.57% 5/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Postoperative wound infection	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.32% 3/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Respiratory tract infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Rotavirus infection	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Streptococcal bacteraemia	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Upper respiratory tract infection	0.43% 4/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.43% 4/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Urinary tract infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Viral infection	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Escherichia urinary tract infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Exanthema subitum	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Osteomyelitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Parainfluenzae virus infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Periorbital cellulitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Pneumococcal bacteraemia	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Pneumonia influenzal	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Pneumonia viral	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Acute tonsillitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Herpangina	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Tonsillitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Arthritis bacterial	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Cellulitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Corynebacterium infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Endophthalmitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations H1N1 influenza	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Influenza	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Intervertebral discitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Localised infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Pulmonary tuberculosis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Sinusitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Subcutaneous abscess	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Tooth abscess	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Wound infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Fall	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Head injury	0.32% 3/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.43% 4/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.45% 4/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Exposure to toxic agent	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Foreign body	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Near drowning	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Laceration	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Investigations Urine analysis abnormal	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Investigations Influenza virus test positive	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Metabolism and nutrition disorders Dehydration	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.91% 8/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.69% 6/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Metabolism and nutrition disorders Diet refusal	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Metabolism and nutrition disorders Lactose intolerance	0.22% 2/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Metabolism and nutrition disorders Weight gain poor	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Metabolism and nutrition disorders Feeding disorder	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Musculoskeletal and connective tissue disorders Monarthritis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medulloblastoma	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Nervous system disorders Cerebral infarction	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Nervous system disorders Convulsion	0.22% 2/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Nervous system disorders Febrile convulsion	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.54% 5/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.79% 7/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.91% 8/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Nervous system disorders Fontanelle bulging	0.22% 2/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Nervous system disorders Hypotonia	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Nervous system disorders Partial seizures	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Nervous system disorders Infantile spasms	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Nervous system disorders Status epilepticus	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Nervous system disorders Myoclonic epilepsy	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Pregnancy, puerperium and perinatal conditions Cephalhaematoma	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Psychiatric disorders Breath holding	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Psychiatric disorders Restlessness	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Psychiatric disorders Apathy	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Renal and urinary disorders Leukocyturia	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Renal and urinary disorders Kidney enlargement	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Renal and urinary disorders Dysuria	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Reproductive system and breast disorders Testicular torsion	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Apparent life threatening event	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Asthma	0.22% 2/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.79% 7/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.57% 5/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Choking	0.32% 3/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Grunting	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.22% 2/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Stridor	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Wheezing	0.22% 2/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.22% 2/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Skin and subcutaneous tissue disorders Rash	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Rash macular	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Social circumstances Overfeeding of infant	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Vascular disorders Hypertension	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Accidental poisoning	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Contusion	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Mouth injury	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Postoperative fever	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.

Other adverse events

Other adverse events
Measure	Infant Series 13vPnC n=930 participants at risk Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.	Infant Series 7vPnC n=933 participants at risk Participants who received 7vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.	After Infant Series 13vPnC n=929 participants at risk Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.	After Infant Series 7vPnC n=931 participants at risk Participants who received 7vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.	Toddler Dose 13vPnC n=882 participants at risk Participants who received 13vPnC 0.5 mL intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.	Toddler Dose 7vPnC n=875 participants at risk Participants who received 7vPnC 0.5 mL dose intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.	After Toddler Dose 13vPnC n=882 participants at risk Participants who received 13vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.	After Toddler Dose 7vPnC n=875 participants at risk Participants who received 7vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.
Infections and infestations Acute tonsillitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.45% 4/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Gingivitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Ear and labyrinth disorders Tympanic membrane hyperaemia	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Blood and lymphatic system disorders Leukocytosis	0.65% 6/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.96% 9/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.4% 13/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.8% 17/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.45% 4/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.46% 4/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.7% 15/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.7% 15/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Blood and lymphatic system disorders Leukopenia	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Blood and lymphatic system disorders Neutropenia	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Ear and labyrinth disorders Otorrhoea	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Eye disorders Conjunctivitis	0.22% 2/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.46% 4/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Eye disorders Eye swelling	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Abdominal pain	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Diarrhoea	1.7% 16/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.96% 9/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.4% 13/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.86% 8/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.45% 4/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.80% 7/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	2.8% 25/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	3.9% 34/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Vomiting	0.22% 2/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.43% 4/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.5% 13/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.91% 8/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Constipation	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Cheilitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Haematochezia	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Lip swelling	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Stomatitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Gastrointestinal disorders Swollen tongue	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
General disorders Inflammation	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
General disorders Injection site erythema	0.43% 4/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
General disorders Injection site swelling	1.5% 14/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.1% 10/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.68% 6/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
General disorders Pyrexia	23.2% 216/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	20.8% 194/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	3.4% 32/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	4.0% 37/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	10.2% 90/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	10.2% 89/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	7.3% 64/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	7.8% 68/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
General disorders Developmental delay	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
General disorders Gait disturbance	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
General disorders Oedema peripheral	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
General disorders Chills	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Immune system disorders Food allergy	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Bacteraemia	0.54% 5/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.22% 2/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.57% 5/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Bronchiolitis	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.57% 5/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.5% 13/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Bronchitis	0.22% 2/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.54% 5/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.0% 9/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.1% 10/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Cellulitis	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.54% 5/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.68% 6/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.57% 5/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Dysentery	0.65% 6/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.43% 4/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.43% 4/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.64% 6/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.1% 10/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.5% 13/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Ear infection	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Gastroenteritis	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.79% 7/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Influenza	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Lower respiratory tract infection	0.22% 2/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.22% 2/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.46% 4/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Meningitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Otitis media	17.7% 165/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	14.7% 137/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	18.9% 176/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	20.9% 195/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	10.5% 93/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	10.5% 92/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	30.3% 267/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	28.1% 246/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Otitis media acute	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Paronychia	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Investigations Pharyngitis	1.3% 12/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	2.6% 24/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	3.8% 35/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	3.4% 32/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	3.9% 34/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	3.1% 27/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	12.7% 112/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	13.0% 114/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Pneumonia	1.7% 16/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.5% 14/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	2.3% 21/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	2.7% 25/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.79% 7/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.5% 13/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	6.5% 57/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	6.6% 58/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Rhinitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.43% 4/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.79% 7/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Tonsillitis	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.0% 9/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.5% 13/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Upper respiratory tract infection	1.4% 13/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.54% 5/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.3% 12/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.6% 15/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.3% 11/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	4.2% 37/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	4.9% 43/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Urinary tract infection	1.2% 11/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.7% 16/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.1% 10/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.54% 5/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.1% 10/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.69% 6/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Adenoiditis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Anal abscess	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Cellulitis orbital	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Hordeolum	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Impetigo	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.69% 6/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Infectious mononucleosis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Localised infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Nasopharyngitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Pertussis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Respiratory tract infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Sinusitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Varicella	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Viral infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Wound infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Bullous impetigo	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Oral candidiasis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Periorbital cellulitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.57% 5/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Subcutaneous abscess	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Abscess	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Brucellosis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Erysipelas	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations External ear cellulitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Infected bites	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Oral infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Parotitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Scarlet fever	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Skin infection	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Tooth abscess	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Tracheitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Limb injury	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Animal bite	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Head injury	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Contusion	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Fracture	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Laceration	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Postoperative fever	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Injury, poisoning and procedural complications Tooth injury	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Investigations Laboratory test	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Investigations Urine analysis abnormal	0.32% 3/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Investigations White blood cells urine positive	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Metabolism and nutrition disorders Weight gain poor	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Musculoskeletal and connective tissue disorders Monarthritis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Nervous system disorders Somnolence	0.54% 5/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Nervous system disorders Nervous system disorder	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Nervous system disorders Febrile convulsion	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Psychiatric disorders Restlessness	10.5% 98/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	9.5% 89/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.2% 11/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.3% 11/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Psychiatric disorders Apathy	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Renal and urinary disorders Dysuria	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Renal and urinary disorders Vesicoureteric reflux	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Choking	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Cough	1.2% 11/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.43% 4/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.86% 8/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	1.1% 10/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.45% 4/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	3.5% 31/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	2.3% 20/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.32% 3/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.22% 2/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.32% 3/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Stridor	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Wheezing	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.21% 2/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.43% 4/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.34% 3/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Skin and subcutaneous tissue disorders Rash	0.11% 1/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.23% 2/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Surgical and medical procedures Antibiotic prophylaxis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.
Infections and infestations Osteomyelitis	0.00% 0/930 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/933 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/929 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/931 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.11% 1/882 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.	0.00% 0/875 Safety population: all randomized participants with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or one subject may have experienced both a serious and nonserious event during study.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER