Trial Outcomes & Findings for A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable (NCT NCT03428100)

NCT ID: NCT03428100

Last Updated: 2024-05-14

Results Overview

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 463 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2024-05-14

Participant Flow

Participant milestones

Measure	Placebo Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	1 mg Baricitinib 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind. .	2 mg Baricitinib 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	Long Term Extension(LTE) Substudy 4mg Baricitinib to 4mg Baricitinib (Responders/Partial Responders) 4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Substudy 4 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders) 4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Substudy 2 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders) 2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Substudy 2 mg Baricitinib to 1 mg Baricitinib (Responders/Partial Responders) 2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy 4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy 2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy 1 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	LTE 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 2 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy 2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 2 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy 2 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 1 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy 1 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 1 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy 1 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Placebo to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy Placebo rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Placebo to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy Placebo rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Double-Blind Treatment Week 0 to Week 52 STARTED	93	93	185	92	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Double-Blind Treatment Week 0 to Week 52 Received at Least One Dose of Study Drug	93	93	184	92	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Double-Blind Treatment Week 0 to Week 52 COMPLETED	72	80	173	85	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Double-Blind Treatment Week 0 to Week 52 NOT COMPLETED	21	13	12	7	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Long-Term Extension Week 52 to Week 200 STARTED	0	0	0	0	16	16	25	24	7	22	34	29	24	27	26	13	14	11	12
Long-Term Extension Week 52 to Week 200 COMPLETED	0	0	0	0	2	6	5	6	3	5	5	10	1	6	4	4	1	1	2
Long-Term Extension Week 52 to Week 200 NOT COMPLETED	0	0	0	0	14	10	20	18	4	17	29	19	23	21	22	9	13	10	10

Reasons for withdrawal

Measure	Placebo Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	1 mg Baricitinib 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind. .	2 mg Baricitinib 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	Long Term Extension(LTE) Substudy 4mg Baricitinib to 4mg Baricitinib (Responders/Partial Responders) 4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Substudy 4 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders) 4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Substudy 2 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders) 2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Substudy 2 mg Baricitinib to 1 mg Baricitinib (Responders/Partial Responders) 2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy 4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy 2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy 1 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	LTE 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 2 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy 2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 2 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy 2 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 1 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy 1 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 1 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy 1 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Placebo to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy Placebo rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Placebo to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy Placebo rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Double-Blind Treatment Week 0 to Week 52 Adverse Event	1	0	3	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Double-Blind Treatment Week 0 to Week 52 Lack of Efficacy	16	10	7	6	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Double-Blind Treatment Week 0 to Week 52 Protocol Deviation	0	2	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Double-Blind Treatment Week 0 to Week 52 Withdrawal by Subject	4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Double-Blind Treatment Week 0 to Week 52 Physician Decision	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Long-Term Extension Week 52 to Week 200 Adverse Event	0	0	0	0	0	4	1	2	1	0	1	0	3	1	1	1	2	0	0
Long-Term Extension Week 52 to Week 200 Death	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Long-Term Extension Week 52 to Week 200 Lack of Efficacy	0	0	0	0	2	2	3	4	0	4	4	0	9	9	6	3	4	4	1
Long-Term Extension Week 52 to Week 200 Lost to Follow-up	0	0	0	0	0	0	0	1	0	0	0	2	1	0	2	0	0	1	0
Long-Term Extension Week 52 to Week 200 Other	0	0	0	0	0	0	2	0	0	0	0	1	0	0	0	0	0	2	1
Long-Term Extension Week 52 to Week 200 Physician Decision	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1
Long-Term Extension Week 52 to Week 200 Study Terminated by Sponsor	0	0	0	0	10	4	8	8	3	7	11	11	8	6	12	5	3	1	7
Long-Term Extension Week 52 to Week 200 Withdrawal by Subject	0	0	0	0	2	0	5	2	0	6	13	5	2	5	1	0	4	2	0

Baseline Characteristics

A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable

Baseline characteristics by cohort

Measure	Placebo n=93 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	1 mg Baricitinib n=93 Participants 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind. .	2 mg Baricitinib n=185 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	Total n=463 Participants Total of all reporting groups
Age, Continuous	38.7 years STANDARD_DEVIATION 13.6 • n=5 Participants	38.9 years STANDARD_DEVIATION 14.0 • n=7 Participants	37.3 years STANDARD_DEVIATION 13.6 • n=5 Participants	38.7 years STANDARD_DEVIATION 13.3 • n=4 Participants	38.2 years STANDARD_DEVIATION 13.6 • n=21 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	35 Participants n=7 Participants	52 Participants n=5 Participants	35 Participants n=4 Participants	166 Participants n=21 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	58 Participants n=7 Participants	133 Participants n=5 Participants	57 Participants n=4 Participants	297 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants	14 Participants n=4 Participants	64 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	62 Participants n=7 Participants	101 Participants n=5 Participants	55 Participants n=4 Participants	272 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	28 Participants n=5 Participants	18 Participants n=7 Participants	58 Participants n=5 Participants	23 Participants n=4 Participants	127 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants	18 Participants n=4 Participants	89 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	70 Participants n=7 Participants	145 Participants n=5 Participants	71 Participants n=4 Participants	360 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment Austria	1 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants	10 participants n=21 Participants
Region of Enrollment Netherlands	3 participants n=5 Participants	0 participants n=7 Participants	9 participants n=5 Participants	4 participants n=4 Participants	16 participants n=21 Participants
Region of Enrollment Belgium	3 participants n=5 Participants	5 participants n=7 Participants	12 participants n=5 Participants	6 participants n=4 Participants	26 participants n=21 Participants
Region of Enrollment Finland	2 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	7 participants n=21 Participants
Region of Enrollment Poland	10 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants	7 participants n=4 Participants	41 participants n=21 Participants
Region of Enrollment Brazil	8 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants	10 participants n=4 Participants	48 participants n=21 Participants
Region of Enrollment Italy	11 participants n=5 Participants	9 participants n=7 Participants	13 participants n=5 Participants	4 participants n=4 Participants	37 participants n=21 Participants
Region of Enrollment France	9 participants n=5 Participants	6 participants n=7 Participants	16 participants n=5 Participants	8 participants n=4 Participants	39 participants n=21 Participants
Region of Enrollment Germany	15 participants n=5 Participants	18 participants n=7 Participants	37 participants n=5 Participants	18 participants n=4 Participants	88 participants n=21 Participants
Region of Enrollment Japan	15 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants	16 participants n=4 Participants	79 participants n=21 Participants
Region of Enrollment Russia	5 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants	2 participants n=4 Participants	14 participants n=21 Participants
Region of Enrollment Spain	7 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants	6 participants n=4 Participants	35 participants n=21 Participants
Region of Enrollment Switzerland	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	4 participants n=21 Participants
Region of Enrollment United Kingdom	4 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants	4 participants n=4 Participants	19 participants n=21 Participants

PRIMARY outcome

Timeframe: Week 16

Population: All participants randomized to placebo, 2 mg or 4 mg of study drug.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

Outcome measures

Measure	Placebo n=93 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=185 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (Placebo, 2 mg or 4 mg Baricitinib)	17.2 percentage of participants Interval 10.9 to 26.1	27.6 percentage of participants Interval 21.6 to 34.4	31.5 percentage of participants Interval 22.9 to 41.6	—

SECONDARY outcome

Timeframe: Week 16

Population: All participants randomized to placebo or 1 mg of study drug.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

Missing values were imputed using Non-Responder Imputation (NRI), where non-responders were participants who permanently discontinue, are rescued, or are without at least 1 post-baseline observation.

Outcome measures

Measure	Placebo n=93 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=93 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants Achieving EASI75 (Placebo, 1 mg Baricitinib)	17.2 percentage of participants Interval 10.9 to 26.1	22.6 percentage of participants Interval 15.3 to 32.1	—	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Outcome measures

Measure	Placebo n=93 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=93 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=185 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement	9.7 percentage of participants Interval 5.2 to 17.4	12.9 percentage of participants Interval 7.5 to 21.2	15.1 percentage of participants Interval 10.7 to 21.0	21.7 percentage of participants Interval 14.5 to 31.2

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.

Outcome measures

Measure	Placebo n=93 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=93 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=185 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants Achieving EASI90	6.5 percentage of participants Interval 3.0 to 13.4	8.6 percentage of participants Interval 4.4 to 16.1	10.3 percentage of participants Interval 6.7 to 15.5	14.1 percentage of participants Interval 8.4 to 22.7

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with Week 16 EASI data.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease).

Least Squares Mean (LSM) were calculated using mixed model repeated measures (MMRM) model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline score and baseline score-by-visit-interaction as fixed continuous effects.

Outcome measures

Measure	Placebo n=54 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=61 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=144 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=65 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percent Change From Baseline in EASI Score	-42.69 percent change Standard Error 4.135	-60.34 percent change Standard Error 4.018	-56.05 percent change Standard Error 2.755	-63.31 percent change Standard Error 3.922

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants.

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.

The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.

Outcome measures

Measure	Placebo n=93 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=93 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=185 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)	1.1 percentage of participants Interval 0.2 to 5.8	6.5 percentage of participants Interval 3.0 to 13.4	8.1 percentage of participants Interval 5.0 to 12.9	6.5 percentage of participants Interval 3.0 to 13.5

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants with a baseline Itch NRS score \>=4.

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.

Outcome measures

Measure	Placebo n=85 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=78 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=166 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=76 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)	8.2 percentage of participants Interval 4.0 to 16.0	23.1 percentage of participants Interval 15.1 to 33.6	22.9 percentage of participants Interval 17.2 to 29.9	38.2 percentage of participants Interval 28.1 to 49.4

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with Week 16 ADSS Item 2 (frequency of waking) data.

The ADSS is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep due to itch, frequency of waking due to itch, and difficulty getting back to sleep last night due to itch. Item 2 frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually.

LS Mean were calculated using an MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Measure	Placebo n=53 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=62 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=135 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=66 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)	-0.63 units on a scale Standard Error 0.149	-1.05 units on a scale Standard Error 0.142	-0.85 units on a scale Standard Error 0.099	-1.42 units on a scale Standard Error 0.140

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with Week 16 Skin Pain NRS data.

Skin Pain NRS is a participant-administered,11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours.

LS Mean were calculated using MMRM model includes treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Measure	Placebo n=53 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=62 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=135 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=66 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Change From Baseline in Skin Pain NRS	-1.56 units on a scale Standard Error 0.284	-2.27 units on a scale Standard Error 0.274	-2.40 units on a scale Standard Error 0.193	-3.02 units on a scale Standard Error 0.271

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Outcome measures

Measure	Placebo n=93 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=93 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=185 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants Achieving IGA of 0 or 1 With a >=2-point Improvement	12.9 percentage of participants Interval 7.5 to 21.2	20.4 percentage of participants Interval 13.5 to 29.7	18.9 percentage of participants Interval 13.9 to 25.2	13.0 percentage of participants Interval 7.6 to 21.4

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI50 is defined as a ≥ 50% improvement from baseline in the EASI score.

Outcome measures

Measure	Placebo n=93 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=93 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=185 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants Achieving EASI50	35.5 percentage of participants Interval 26.5 to 45.6	45.2 percentage of participants Interval 35.4 to 55.3	51.4 percentage of participants Interval 44.2 to 58.5	52.2 percentage of participants Interval 42.1 to 62.1

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

Outcome measures

Measure	Placebo n=93 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=93 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=185 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants Achieving EASI75	17.2 percentage of participants Interval 10.9 to 26.1	30.1 percentage of participants Interval 21.7 to 40.1	27.6 percentage of participants Interval 21.6 to 34.4	25.0 percentage of participants Interval 17.3 to 34.7

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Outcome measures

Measure	Placebo n=93 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=93 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=185 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants Achieving IGA of 0	0.00 percentage of participants Interval 0.0 to 4.0	2.2 percentage of participants Interval 0.6 to 7.5	1.1 percentage of participants Interval 0.3 to 3.9	3.3 percentage of participants Interval 1.1 to 9.2

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with Week 16 SCORAD data.

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.

LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Measure	Placebo n=54 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=60 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=142 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=64 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Change From Baseline in SCORAD	-21.98 units on a scale Standard Error 2.171	-28.06 units on a scale Standard Error 2.097	-28.54 units on a scale Standard Error 1.438	-31.74 units on a scale Standard Error 2.052

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants.

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the SCORAD score.

Outcome measures

Measure	Placebo n=93 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=93 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=185 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants Achieving SCORAD90	0.00 percentage of participants Interval 0.0 to 4.0	2.2 percentage of participants Interval 0.6 to 7.5	1.1 percentage of participants Interval 0.3 to 3.9	2.2 percentage of participants Interval 0.6 to 7.6

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with Week 16 BSA data.

The BSA affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSAhead and neck + 0.3*BSAtrunk + 0.2* BSAupper limbs + 0.4*BSAlower limbs.

LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Measure	Placebo n=54 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=61 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=144 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=65 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Change From Baseline in Body Surface Area (BSA) Affected	-19.76 units on a scale Standard Error 2.257	-25.98 units on a scale Standard Error 2.178	-25.26 units on a scale Standard Error 1.488	-28.17 units on a scale Standard Error 2.125

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants who received at least one dose of study drug and who did not discontinue from the study for the reason of "Lost to Follow-up" at the first post-baseline visit.

Percentage of participants developing skin infections requiring antibiotic treatment.

Outcome measures

Measure	Placebo n=93 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=93 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=184 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment	5.4 percentage of participants	6.5 percentage of participants	6.5 percentage of participants	5.4 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants without use of TCS.

The ANCOVA model includes treatment, region, and baseline disease severity (IGA) as factors.

Outcome measures

Measure	Placebo n=89 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=92 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=178 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=89 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Mean Number of Days Without Topical Corticosteroids (TCS) Use	12.18 days Standard Error 3.39	20.80 days Standard Error 3.37	17.65 days Standard Error 2.53	19.43 days Standard Error 3.41

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants.

Average weights of full tubes were used to determine the dispensed weights for each region. Returned tubes were weighed with cap without carton to determine the amount of TCS in grams (g) used at each visit. Analysis was done via analysis of variance (ANOVA), with geographic region, baseline disease severity, and treatment as factors in the model.

Outcome measures

Measure	Placebo n=93 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=93 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=185 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Mean Gram Quantity of Low and Moderate Potency Background Topical Corticosteroid (TCS) Used (Tube Weights)	242.59 grams Standard Error 27.60	194.53 grams Standard Error 27.42	185.70 grams Standard Error 20.67	171.17 grams Standard Error 27.16

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with Week 16 Itch NRS data.

The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.

LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects.

Outcome measures

Measure	Placebo n=53 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=62 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=135 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=66 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percent Change From Baseline in Itch NRS	-17.48 percent change Standard Error 4.835	-28.80 percent change Standard Error 4.663	-32.89 percent change Standard Error 3.258	-37.24 percent change Standard Error 4.609

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants with Week 24 itch NRS data.

The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.

LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects.

Outcome measures

Measure	Placebo n=35 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=50 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=108 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=54 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percent Change From Baseline in Itch NRS at Week 24	-15.35 units on a scale Standard Error 5.349	-29.35 units on a scale Standard Error 5.039	-30.11 units on a scale Standard Error 3.495	-33.16 units on a scale Standard Error 4.972

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with Week 16 POEM data.

The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.

LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by visit-interactions as fixed continuous effects.

Outcome measures

Measure	Placebo n=55 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=62 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=145 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=67 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)	-4.18 units on a scale Standard Error 0.907	-6.24 units on a scale Standard Error 0.872	-7.27 units on a scale Standard Error 0.602	-9.27 units on a scale Standard Error 0.855

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with Week 16 PGI-S-AD data.

The PGI-S-AD is a single-item question asking the participant how they would rate their overall AD symptoms over the past 24 hours, using a daily diary. The 5 categories of responses are "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe."

LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Measure	Placebo n=53 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=62 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=135 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=66 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Change From Baseline in the Patient Global Impression of Severity - Atopic Dermatitis (PGI-S-AD) Score	-0.49 units on a scale Standard Error 0.107	-0.74 units on a scale Standard Error 0.103	-0.77 units on a scale Standard Error 0.072	-1.07 units on a scale Standard Error 0.101

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with Week 16 HADS data.

The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'

LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Measure	Placebo n=55 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=62 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=145 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=67 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Change From Baseline on the Hospital Anxiety Depression Scale (HADS) Anxiety	-0.48 units on a scale Standard Error 0.382	-1.04 units on a scale Standard Error 0.366	-1.59 units on a scale Standard Error 0.256	-1.32 units on a scale Standard Error 0.362
Change From Baseline on the Hospital Anxiety Depression Scale (HADS) Depression	-0.40 units on a scale Standard Error 0.383	-0.69 units on a scale Standard Error 0.367	-1.03 units on a scale Standard Error 0.256	-1.57 units on a scale Standard Error 0.362

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with Week 16 DLQI data.

The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered or "not relevant" responses scored as "0." Scores range from 0 to 30 ("no impact on participant's life" to "extremely large effect on participant's life"), and a 4-point change from baseline is considered as the minimal clinically important difference threshold.

LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Measure	Placebo n=55 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=62 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=145 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=67 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Change From Baseline in the Dermatology Life Quality Index (DLQI)	-4.95 units on a scale Standard Error 0.752	-6.18 units on a scale Standard Error 0.719	-6.57 units on a scale Standard Error 0.494	-7.95 units on a scale Standard Error 0.705

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with Week 16 WPAI-AD data.

The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment.

LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Measure	Placebo n=55 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=62 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=145 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=67 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire Activity Impairment	-16.46 units on a scale Standard Error 2.853	-18.46 units on a scale Standard Error 2.729	-20.86 units on a scale Standard Error 1.847	-23.92 units on a scale Standard Error 2.660
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire Absenteeism	-4.77 units on a scale Standard Error 2.365	-5.69 units on a scale Standard Error 2.433	-2.98 units on a scale Standard Error 1.639	-4.56 units on a scale Standard Error 2.258
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire Presenteeism	-14.86 units on a scale Standard Error 3.182	-11.80 units on a scale Standard Error 3.161	-14.56 units on a scale Standard Error 2.133	-14.81 units on a scale Standard Error 3.000
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire Work Productivity Loss	-13.22 units on a scale Standard Error 3.560	-12.07 units on a scale Standard Error 3.565	-13.07 units on a scale Standard Error 2.440	-14.12 units on a scale Standard Error 3.396

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with EQ-5D-5L US and UK Health scores.

The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state.

LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Measure	Placebo n=55 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=62 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=145 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=67 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm US Health State Index	0.04 units on a scale Standard Error 0.016	0.08 units on a scale Standard Error 0.016	0.09 units on a scale Standard Error 0.011	0.11 units on a scale Standard Error 0.015
Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm UK Health State Index	0.06 units on a scale Standard Error 0.023	0.11 units on a scale Standard Error 0.022	0.13 units on a scale Standard Error 0.016	0.15 units on a scale Standard Error 0.022

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with Week 16 EQ-5D-5L VAS data.

EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.

LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Outcome measures

Measure	Placebo n=55 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=62 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=145 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=67 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)	7.64 millimeters (mm) Standard Error 2.407	11.63 millimeters (mm) Standard Error 2.306	8.76 millimeters (mm) Standard Error 1.588	11.03 millimeters (mm) Standard Error 2.260

SECONDARY outcome

Timeframe: Week 52

Population: All randomized participants.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

Outcome measures

Measure	Placebo n=93 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=93 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=185 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants Achieving EASI75	26.9 Percentage of participants Interval 18.9 to 36.7	33.3 Percentage of participants Interval 24.6 to 43.4	30.3 Percentage of participants Interval 24.1 to 37.2	37.0 Percentage of participants Interval 27.8 to 47.2

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All randomized participants with Week 52 Itch NRS data.

The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.

LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects.

Outcome measures

Measure	Placebo n=44 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=54 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=110 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=56 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percent Change From Baseline in Itch NRS at Week 52	-12.13 Percent Change Standard Error 7.075	-19.49 Percent Change Standard Error 6.679	-16.01 Percent Change Standard Error 4.729	-29.31 Percent Change Standard Error 6.619

SECONDARY outcome

Timeframe: Week 68

Population: Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).

Outcome measures

Measure	Placebo n=16 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=16 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=25 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=24 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy)	93.8 Percentage of participants Interval 71.7 to 98.9	56.3 Percentage of participants Interval 33.2 to 76.9	84.0 Percentage of participants Interval 65.3 to 93.6	50.0 Percentage of participants Interval 31.4 to 68.6

SECONDARY outcome

Timeframe: Week 104

Population: Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).

Outcome measures

Measure	Placebo n=16 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=16 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=25 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=24 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy)	68.8 Percentage of participants Interval 44.4 to 85.8	50.0 Percentage of participants Interval 28.0 to 72.0	72.0 Percentage of participants Interval 52.4 to 85.7	25.0 Percentage of participants Interval 12.0 to 44.9

SECONDARY outcome

Timeframe: Week 68

Population: Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Outcome measures

Measure	Placebo n=16 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=16 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=25 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=24 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy)	50 Percentage of participants Interval 28.0 to 72.0	25.0 Percentage of participants Interval 10.2 to 49.5	44.0 Percentage of participants Interval 26.7 to 62.9	20.8 Percentage of participants Interval 9.2 to 40.5

SECONDARY outcome

Timeframe: Week 104

Population: Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Outcome measures

Measure	Placebo n=16 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=16 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=25 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=24 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy)	43.8 Percentage of participants Interval 23.1 to 66.8	25.0 Percentage of participants Interval 10.2 to 49.5	44.0 Percentage of participants Interval 26.7 to 62.9	8.3 Percentage of participants Interval 2.3 to 25.8

SECONDARY outcome

Timeframe: Week 68

Population: Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

Outcome measures

Measure	Placebo n=16 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=16 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=25 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=24 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of EASI75 From Baseline Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy)	75.0 Percentage of participants Interval 50.5 to 89.8	56.3 Percentage of participants Interval 33.2 to 76.9	72.0 Percentage of participants Interval 52.4 to 85.7	41.7 Percentage of participants Interval 24.5 to 61.2

SECONDARY outcome

Timeframe: Week 104

Population: Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

Outcome measures

Measure	Placebo n=16 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=16 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=25 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=24 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of EASI75 From Baseline Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy)	68.8 Percentage of participants Interval 44.4 to 85.8	56.3 Percentage of participants Interval 33.2 to 76.9	56.0 Percentage of participants Interval 37.1 to 73.3	33.3 Percentage of participants Interval 18.0 to 53.3

SECONDARY outcome

Timeframe: Week 68

Population: Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy with IGA 0 or 1 at Week 52. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).

Outcome measures

Measure	Placebo n=10 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=9 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=10 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=9 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)	100 Percentage of participants Interval 72.2 to 100.0	77.8 Percentage of participants Interval 45.3 to 93.7	100 Percentage of participants Interval 72.2 to 100.0	55.6 Percentage of participants Interval 26.7 to 81.1

SECONDARY outcome

Timeframe: Week 104

Population: Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy with IGA 0 or 1 at Week 52. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.

Outcome measures

Measure	Placebo n=10 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=9 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=10 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=9 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)	80.0 Percentage of participants Interval 49.0 to 94.3	66.7 Percentage of participants Interval 35.4 to 87.9	100 Percentage of participants Interval 72.2 to 100.0	33.3 Percentage of participants Interval 12.1 to 64.6

SECONDARY outcome

Timeframe: Week 68

Population: Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy with IGA 0 or 1 at Week 52. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.

Outcome measures

Measure	Placebo n=10 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=9 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=10 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=9 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)	60.0 Percentage of participants Interval 31.3 to 83.2	33.3 Percentage of participants Interval 12.1 to 64.6	90.0 Percentage of participants Interval 59.6 to 98.2	55.6 Percentage of participants Interval 26.7 to 81.1

SECONDARY outcome

Timeframe: Week 104

Population: Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy with IGA 0 or 1 at Week 52. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.

Outcome measures

Measure	Placebo n=10 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=9 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=10 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=9 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)	50.0 Percentage of participants Interval 23.7 to 76.3	33.3 Percentage of participants Interval 12.1 to 64.6	90.0 Percentage of participants Interval 59.6 to 98.2	22.2 Percentage of participants Interval 6.3 to 54.7

SECONDARY outcome

Timeframe: Week 68

Population: Participants who received at least one study medication Week 52 to Week 200 in Study JAIN, and were Responders (IGA 0 or 1) and Partial Responders (IGA 2) at Week 52 but were not eligible for downtitration substudy (i.e. had study drug interrupted at Week 52, or had received high or ultra-high potency TCS in the previous 14 days). Additionally, those participants who did not met study discontinuation criteria and continued will be considered in the analysis set.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.

Outcome measures

Measure	Placebo n=7 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=22 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=34 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=29 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 68 Participants Not Entered Into Substudy (All Participants)	100 Percentage of participants Interval 64.6 to 100.0	86.4 Percentage of participants Interval 66.7 to 95.3	100 Percentage of participants Interval 89.8 to 100.0	93.1 Percentage of participants Interval 78.0 to 98.1

SECONDARY outcome

Timeframe: Week 104

Population: Participants who received at least one study medication Week 52 to Week 200 in Study JAIN, and were Responders (IGA 0 or 1) and Partial Responders (IGA 2) at Week 52 but were not eligible for downtitration substudy (i.e. had study drug interrupted at Week 52, or had received high or ultra-high potency TCS in the previous 14 days). Additionally, those participants who did not met study discontinuation criteria and continued will be considered in the analysis set.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.

Outcome measures

Measure	Placebo n=7 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=22 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=34 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=29 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 Participants Not Entered Into Substudy (All Participants)	100 Percentage of participants Interval 64.6 to 100.0	86.4 Percentage of participants Interval 66.7 to 95.3	97.1 Percentage of participants Interval 85.1 to 99.5	93.1 Percentage of participants Interval 78.0 to 98.1

SECONDARY outcome

Timeframe: Week 68

Population: Participants who received at least one study medication Week 52 to Week 200 in Study JAIN, and were Responders (IGA 0 or 1) and Partial Responders (IGA 2) at Week 52 but were not eligible for downtitration substudy (i.e. had study drug interrupted at Week 52, or had received high or ultra-high potency TCS in the previous 14 days). Additionally, those participants who did not met study discontinuation criteria and continued will be considered in the analysis set.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.

Outcome measures

Measure	Placebo n=7 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=22 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=34 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=29 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 68 - Participants Not Entered Into Substudy (All Participants)	14.3 Percentage of participants Interval 2.6 to 51.3	50.0 Percentage of participants Interval 30.7 to 69.3	47.1 Percentage of participants Interval 31.5 to 63.3	51.7 Percentage of participants Interval 34.4 to 68.6

SECONDARY outcome

Timeframe: Week 104

Population: Participants who received at least one study medication Week 52 to Week 200 in Study JAIN, and were Responders (IGA 0 or 1) and Partial Responders (IGA 2) at Week 52 but were not eligible for downtitration substudy (i.e. had study drug interrupted at Week 52, or had received high or ultra-high potency TCS in the previous 14 days). Additionally, those participants who did not met study discontinuation criteria and continued will be considered in the analysis set.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.

Outcome measures

Measure	Placebo n=7 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=22 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=34 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=29 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 - Participants Not Entered Into Substudy (All Participants)	42.9 Percentage of participants Interval 15.8 to 75.0	50.0 Percentage of participants Interval 30.7 to 69.3	47.1 Percentage of participants Interval 31.5 to 63.3	48.3 Percentage of participants Interval 31.4 to 65.6

SECONDARY outcome

Timeframe: Week 68

Population: Participants who received at least one study medication Week 52 to Week 200 in Study JAIN, and were Responders (IGA 0 or 1) and Partial Responders (IGA 2) at Week 52 but were not eligible for downtitration substudy (i.e. had study drug interrupted at Week 52, or had received high or ultra-high potency TCS in the previous 14 days). Additionally, those participants who did not met study discontinuation criteria and continued will be considered in the analysis set.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

Outcome measures

Measure	Placebo n=7 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=22 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=34 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=29 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With A Response of EASI75 Assessed at Week 68 - Participants Not Entered Into Substudy (All Participants)	57.1 Percentage of participants Interval 25.0 to 84.2	63.6 Percentage of participants Interval 43.0 to 80.3	76.5 Percentage of participants Interval 60.0 to 87.6	62.1 Percentage of participants Interval 44.0 to 77.3

SECONDARY outcome

Timeframe: Week 104

Population: Participants who received at least one study medication Week 52 to Week 200 in Study JAIN, and were Responders (IGA 0 or 1) and Partial Responders (IGA 2) at Week 52 but were not eligible for downtitration substudy (i.e. had study drug interrupted at Week 52, or had received high or ultra-high potency TCS in the previous 14 days). Additionally, those participants who did not met study discontinuation criteria and continued will be considered in the analysis set.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.

Outcome measures

Measure	Placebo n=7 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=22 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=34 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=29 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With A Response of EASI75 Assessed at Week 104 - Participants Not Entered Into Substudy (All Participants)	85.7 Percentage of participants Interval 48.7 to 97.4	68.2 Percentage of participants Interval 47.3 to 83.6	70.6 Percentage of participants Interval 53.8 to 83.2	72.4 Percentage of participants Interval 54.3 to 85.3

SECONDARY outcome

Timeframe: Week 52 Up to Week 200

Population: Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN, entered the downtitration substudy and experienced relapse from Week 52 up to Week 200. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.

Participants who entered the Substudy and relapsed with an IGA ≥3.

Outcome measures

Measure	Placebo n=5 Participants Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	2 mg Baricitinib n=11 Participants 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=15 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=20 Participants 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Time to Retreatment (Time to IGA ≥3) Randomized Downtitration (All Patients Entering the Substudy)	218 Days Interval 29.0 to Upper Confidence Level (CI) not estimable due to censoring.	79 Days Interval 28.0 to 359.0	68 Days Interval 28.0 to 364.0	71 Days Interval 29.0 to 225.0

Adverse Events

Placebo

Serious events: 5 serious events

Other events: 50 other events

Deaths: 0 deaths

1 mg Baricitinib

Serious events: 7 serious events

Other events: 63 other events

Deaths: 0 deaths

2 mg Baricitinib

Serious events: 9 serious events

Other events: 130 other events

Deaths: 0 deaths

4 mg Baricitinib

Serious events: 10 serious events

Other events: 75 other events

Deaths: 0 deaths

Long Term Extension(LTE) Substudy 2mg Baricitinib to 1mg Baricitinib (Responders/Partial Responders)

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

LTE Substudy 2 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders)

Serious events: 4 serious events

Other events: 16 other events

Deaths: 0 deaths

LTE Substudy 4 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders)

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

LTE Substudy 4 mg Baricitinib to 4 mg Baricitinib (Responders/Partial Responders)

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

LTE Placebo to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

LTE Placebo to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

LTE 1 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

LTE 1 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

LTE 2 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

LTE 2 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy

Serious events: 5 serious events

Other events: 18 other events

Deaths: 0 deaths

LTE 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy

Serious events: 4 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=93 participants at risk Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	1 mg Baricitinib n=93 participants at risk 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind. .	2 mg Baricitinib n=184 participants at risk 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 participants at risk 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	Long Term Extension(LTE) Substudy 2mg Baricitinib to 1mg Baricitinib (Responders/Partial Responders) n=24 participants at risk 2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Substudy 2 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders) n=25 participants at risk 2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Substudy 4 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders) n=16 participants at risk 4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Substudy 4 mg Baricitinib to 4 mg Baricitinib (Responders/Partial Responders) n=16 participants at risk 4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy n=29 participants at risk Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy n=34 participants at risk 1 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy n=22 participants at risk 2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy n=7 participants at risk 4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Placebo to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy n=11 participants at risk Placebo rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Placebo to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy n=12 participants at risk Placebo rerandomized to 4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 1 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy n=13 participants at risk 1 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 1 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy n=14 participants at risk 1 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 2 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy n=27 participants at risk 2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 2 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy n=26 participants at risk 2 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy n=24 participants at risk 4 mg administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Skin and subcutaneous tissue disorders Dermatitis atopic	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Acute myocardial infarction	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Cardiac arrest	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Coronary artery disease	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Myocardial ischaemia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Conjunctivitis allergic	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Corneal erosion	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Retinal detachment	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Soft tissue inflammation	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Anal abscess	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cellulitis	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Corneal abscess	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Covid-19	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Eczema herpeticum	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Erysipelas	1.1% 1/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Fracture infection	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Furuncle	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Gastroenteritis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Ophthalmic herpes simplex	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Papilloma viral infection	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Perichondritis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Periorbital cellulitis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Postoperative wound infection	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Peritonitis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia bacterial	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pyelitis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Sepsis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Staphylococcal infection	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Fall	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Injury corneal	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Mouth injury	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Scapula fracture	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/49 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/58 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/132 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/57 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Brain oedema	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Cerebral haemorrhage	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Embolic stroke	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Ischaemic stroke	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Transient ischaemic attack	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Tremor	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Product Issues Device dislocation	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Adjustment disorder	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Suicidal ideation	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hypertrophic scar	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypertensive crisis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.

Other adverse events

Measure	Placebo n=93 participants at risk Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	1 mg Baricitinib n=93 participants at risk 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind. .	2 mg Baricitinib n=184 participants at risk 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	4 mg Baricitinib n=92 participants at risk 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	Long Term Extension(LTE) Substudy 2mg Baricitinib to 1mg Baricitinib (Responders/Partial Responders) n=24 participants at risk 2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Substudy 2 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders) n=25 participants at risk 2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Substudy 4 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders) n=16 participants at risk 4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Substudy 4 mg Baricitinib to 4 mg Baricitinib (Responders/Partial Responders) n=16 participants at risk 4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy n=29 participants at risk Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.	LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy n=34 participants at risk 1 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy n=22 participants at risk 2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy n=7 participants at risk 4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Placebo to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy n=11 participants at risk Placebo rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE Placebo to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy n=12 participants at risk Placebo rerandomized to 4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 1 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy n=13 participants at risk 1 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 1 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy n=14 participants at risk 1 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 2 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy n=27 participants at risk 2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 2 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy n=26 participants at risk 2 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.	LTE 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy n=24 participants at risk 4 mg administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Blood and lymphatic system disorders Anaemia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pharyngitis	4.3% 4/93 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 4/184 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 2/34 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Post-acute covid-19 syndrome	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pulpitis dental	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pyoderma	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Rhinitis	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 6/184 • Number of events 6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 3/92 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 2/34 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Skin infection	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.2% 3/93 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 4/184 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.3% 4/92 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 4/26 • Number of events 6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Subcutaneous abscess	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Suspected covid-19	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Tinea pedis	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Tonsillitis	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.7% 5/184 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Tooth infection	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.3% 4/93 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 7/184 • Number of events 10 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.3% 4/92 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.8% 3/16 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 3/24 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 4/184 • Number of events 7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.4% 5/92 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Vaginal infection	2.3% 1/44 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/35 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/52 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/35 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Viral infection	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/44 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/35 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 2/52 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/35 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Post vaccination syndrome	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 2/34 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Alanine aminotransferase increased	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.7% 5/184 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Arthroscopy	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood alkaline phosphatase increased	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood creatine phosphokinase increased	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.2% 3/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Lymphocyte count decreased	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood creatinine increased	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood triglycerides increased	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Colonoscopy	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Prostatic specific antigen increased	0.00% 0/49 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/58 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/132 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/57 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Sars-cov-2 antibody test positive	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Sars-cov-2 test positive	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Weight increased	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Obesity	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Vitamin d deficiency	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.3% 4/93 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 7/184 • Number of events 8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.4% 5/92 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 2/34 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	5.4% 5/93 • Number of events 6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.5% 6/93 • Number of events 9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 6/184 • Number of events 7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.5% 6/92 • Number of events 9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 2/29 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.2% 3/93 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle contracture	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.2% 3/93 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 2/34 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Neck pain	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.7% 5/184 • Number of events 6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 3/24 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic adenoma	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 4/184 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Iron deficiency anaemia	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Leukopenia	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Neutrophilia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Angina pectoris	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Deafness	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Ear pain	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Vertigo	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Blepharitis	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 4/184 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Conjunctival irritation	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Conjunctivitis allergic	3.2% 3/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.8% 4/29 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Dry eye	4.3% 4/93 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Glaucoma	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Keratoconus	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Lacrimation increased	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Noninfective conjunctivitis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dental caries	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Retinal detachment	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Vitreous floaters	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	3.2% 3/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 7/184 • Number of events 7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.4% 5/92 • Number of events 6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 2/12 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Constipation	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 4/184 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	3.2% 3/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 9/184 • Number of events 10 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.5% 6/92 • Number of events 6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastritis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.3% 8/184 • Number of events 11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Stomatitis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Toothache	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Asthenia	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Fatigue	3.2% 3/93 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.2% 3/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 3/92 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Implant site pain	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Influenza like illness	3.2% 3/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 6/184 • Number of events 6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pyrexia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.2% 3/93 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 2/13 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Anal abscess	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Swelling face	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Abscess	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Bacterial infection	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Bronchitis	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.2% 3/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 7/184 • Number of events 9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.8% 3/16 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Candida infection	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cellulitis	1.1% 1/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Conjunctivitis	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.4% 5/92 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	21.4% 3/14 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Covid-19	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 3/24 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	16.0% 4/25 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 4/16 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.8% 4/29 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	17.6% 6/34 • Number of events 6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.2% 4/22 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	21.4% 3/14 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 4/27 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	19.2% 5/26 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 4/24 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cystitis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Dermatitis infected	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Dermatophytosis of nail	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Ear infection	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 9/184 • Number of events 9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Ear infection bacterial	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Eczema herpeticum	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.0% 2/25 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Erysipelas	1.1% 1/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 4/184 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.3% 4/92 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Folliculitis	2.2% 2/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.7% 9/93 • Number of events 11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 9/184 • Number of events 10 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 2/34 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Furuncle	3.2% 3/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Gastroenteritis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 4/184 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Genital candidiasis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Genital infection bacterial	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Herpes simplex	1.1% 1/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.7% 5/184 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.5% 6/92 • Number of events 7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.8% 3/16 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 2/29 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Herpes zoster	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.3% 4/93 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 6/184 • Number of events 6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 3/92 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.8% 3/34 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.6% 3/22 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 4/26 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Hordeolum	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Impetigo	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.7% 5/184 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Influenza	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.2% 3/93 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.2% 15/184 • Number of events 18 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.2% 14/92 • Number of events 15 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.0% 3/25 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Labyrinthitis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Molluscum contagiosum	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Nasopharyngitis	15.1% 14/93 • Number of events 25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	17.2% 16/93 • Number of events 20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	19.6% 36/184 • Number of events 48 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	37.0% 34/92 • Number of events 45 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 8/24 • Number of events 11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.0% 3/25 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.8% 3/16 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.8% 3/16 • Number of events 7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	10.3% 3/29 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.8% 4/34 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	22.7% 5/22 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	57.1% 4/7 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	50.0% 6/12 • Number of events 7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 3/27 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Ophthalmic herpes simplex	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 2/12 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Oral herpes	6.5% 6/93 • Number of events 6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.4% 5/93 • Number of events 7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 6/184 • Number of events 9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.6% 7/92 • Number of events 13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.0% 2/25 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.6% 3/22 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 2/13 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Otitis externa	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Paronychia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Perichondritis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Peritonsillar abscess	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Diffuse alopecia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 2/34 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Milia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Onycholysis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Urticaria	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Abscess drainage	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Dental implantation	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Intrauterine contraception	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Prostatectomy	0.00% 0/49 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/58 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/132 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/57 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Retinopexy	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Shoulder operation	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Tooth extraction	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Tooth restoration	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Uterine polypectomy	0.00% 0/44 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/35 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/52 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/35 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Vasectomy	0.00% 0/49 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/58 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/132 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/57 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypertension	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.2% 3/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.7% 5/184 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 3/92 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Orthostatic hypotension	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Premature ejaculation	0.00% 0/49 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/58 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/132 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/57 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Dizziness	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Headache	8.6% 8/93 • Number of events 10 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.6% 8/93 • Number of events 15 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.6% 14/184 • Number of events 17 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	10.9% 10/92 • Number of events 13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 5/25 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 2/34 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Migraine	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 2/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 2/12 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Neuralgia	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Paraesthesia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Post herpetic neuralgia	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Tension headache	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Anxiety	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Depressed mood	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 2/34 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Insomnia	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Somatic symptom disorder	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Stress	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Dysuria	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 3/92 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/44 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/35 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/52 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/35 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/44 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.7% 2/35 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/52 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/35 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	23.1% 3/13 • Number of events 9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/44 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/35 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/52 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/35 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Prostatitis	0.00% 0/49 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/58 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/132 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/57 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.8% 1/21 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/9 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 1/9 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/20 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/44 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/35 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/52 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/35 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/6 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asthma	4.3% 4/93 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 3/184 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 2/27 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	1.1% 1/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 9/184 • Number of events 10 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.5% 7/93 • Number of events 10 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 7/184 • Number of events 7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 3/92 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.1% 1/14 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 1/27 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 2/24 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Acne	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.3% 4/93 • Number of events 5 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.3% 8/184 • Number of events 8 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 3/92 • Number of events 3 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.8% 3/34 • Number of events 4 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Alopecia	1.1% 1/93 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.54% 1/184 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/92 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 2/92 • Number of events 2 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/93 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/184 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/92 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/25 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/22 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/14 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/27 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/26 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/24 • Baseline up to Week 200 All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-459-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

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

Restriction type: GT60