Trial Outcomes & Findings for 221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (NCT NCT02477800)

Last Updated: 2021-09-02

Results Overview

CDR-SB integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following caregiver interview and systematic patient examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. Prespecified severity anchors range from none = 0, questionable = 0.5, mild = 1, moderate = 2 to severe = 3 (the personal care domain omits the 0.5 score). "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18 that can change in increments of 0.5 or greater. Higher scores indicate greater disease severity. Mixed model for repeated measures (MMRM) analysis was used to analyze change from baseline in CDR-SB. A positive change from baseline indicates clinical decline.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1653 participants

Primary outcome timeframe

Baseline, Week 78

Results posted on

2021-09-02

Participant Flow

Participants were enrolled at 169 investigational sites in Australia, Austria, Canada, Denmark, France, Germany, Italy, Japan, Portugal, Republic of Korea, Spain, Taiwan, the United Kingdom (UK) and the United States (US) from 13 August, 2015 to 04 July, 2018.

A total of 1653 participants with Alzheimer's disease were enrolled and randomized in the study. Of these, 1647 participants received the study drug in placebo-controlled (PC) period. After completing PC period, 852 participants entered and dosed in long-term extension (LTE) period and no participants completed the study due to early termination of the study.

Participant milestones

Participant milestones
Measure	Placebo (PC Period) Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 Low Dose (PC Period) Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 High Dose (PC Period) Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 Late Start: Low Dose (LTE Period) Following PC period, participants randomized to placebo received BIIB037 low dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.	BIIB037 Late Start: High Dose (LTE Period) Following PC period, participants randomized to placebo received BIIB037 high dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.	BIIB037 Early Start: Low Dose (LTE Period) Following PC period, participants randomized to low dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.	BIIB037 Early Start: High Dose (LTE Period) Following PC period, participants randomized to high dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
Placebo-Controlled Period STARTED	545	547	555	0	0	0	0
Placebo-Controlled Period COMPLETED	325	325	288	0	0	0	0
Placebo-Controlled Period NOT COMPLETED	220	222	267	0	0	0	0
Long Term Extension Period STARTED	0	0	0	150	152	299	251
Long Term Extension Period COMPLETED	0	0	0	0	0	0	0
Long Term Extension Period NOT COMPLETED	0	0	0	150	152	299	251

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (PC Period) Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 Low Dose (PC Period) Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 High Dose (PC Period) Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 Late Start: Low Dose (LTE Period) Following PC period, participants randomized to placebo received BIIB037 low dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.	BIIB037 Late Start: High Dose (LTE Period) Following PC period, participants randomized to placebo received BIIB037 high dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.	BIIB037 Early Start: Low Dose (LTE Period) Following PC period, participants randomized to low dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.	BIIB037 Early Start: High Dose (LTE Period) Following PC period, participants randomized to high dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
Placebo-Controlled Period Adverse Event	16	25	28	0	0	0	0
Placebo-Controlled Period Change of Treatment	1	2	1	0	0	0	0
Placebo-Controlled Period Consent Withdrawn	26	16	27	0	0	0	0
Placebo-Controlled Period Death	0	3	2	0	0	0	0
Placebo-Controlled Period Disease Progression	1	0	1	0	0	0	0
Placebo-Controlled Period Investigator Decision	3	2	1	0	0	0	0
Placebo-Controlled Period Lost to Follow-up	1	3	3	0	0	0	0
Placebo-Controlled Period Relocation	2	0	0	0	0	0	0
Placebo-Controlled Period Site Terminated by Investigator	1	1	1	0	0	0	0
Placebo-Controlled Period Site Terminated by Sponsor	2	1	0	0	0	0	0
Placebo-Controlled Period Study Visit Burden	5	3	11	0	0	0	0
Placebo-Controlled Period Withdrawal by Parent/Guardian	1	5	3	0	0	0	0
Placebo-Controlled Period Reason not Specified	161	161	189	0	0	0	0
Long Term Extension Period Adverse Event	0	0	0	6	2	4	3
Long Term Extension Period Death	0	0	0	1	1	1	2
Long Term Extension Period Consent Withdrawn	0	0	0	10	4	13	16
Long Term Extension Period Disease Progression	0	0	0	3	1	1	0
Long Term Extension Period Investigator Decision	0	0	0	0	0	0	2
Long Term Extension Period Lost to Follow-up	0	0	0	0	1	3	0
Long Term Extension Period Site Terminated By Sponsor	0	0	0	0	0	2	1
Long Term Extension Period Study Visit Burden	0	0	0	3	0	2	2
Long Term Extension Period Withdrawal by Parent/Guardian	0	0	0	1	3	3	1
Long Term Extension Period Reason not Specified	0	0	0	126	140	270	224

Baseline Characteristics

221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo (PC Period) n=545 Participants Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 Low Dose (PC Period) n=547 Participants Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 High Dose (PC Period) n=555 Participants Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	Total n=1647 Participants Total of all reporting groups
Age, Continuous	69.8 years STANDARD_DEVIATION 7.72 • n=5 Participants	70.4 years STANDARD_DEVIATION 6.96 • n=7 Participants	70.0 years STANDARD_DEVIATION 7.65 • n=5 Participants	70.1 years STANDARD_DEVIATION 7.45 • n=4 Participants
Sex: Female, Male Female	287 Participants n=5 Participants	284 Participants n=7 Participants	292 Participants n=5 Participants	863 Participants n=4 Participants
Sex: Female, Male Male	258 Participants n=5 Participants	263 Participants n=7 Participants	263 Participants n=5 Participants	784 Participants n=4 Participants
Race/Ethnicity, Customized Asian	55 Participants n=5 Participants	55 Participants n=7 Participants	65 Participants n=5 Participants	175 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	413 Participants n=5 Participants	412 Participants n=7 Participants	413 Participants n=5 Participants	1238 Participants n=4 Participants
Race/Ethnicity, Customized Not Reported due to Confidentiality Regulations	43 Participants n=5 Participants	44 Participants n=7 Participants	43 Participants n=5 Participants	130 Participants n=4 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	13 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	37 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	489 Participants n=5 Participants	492 Participants n=7 Participants	499 Participants n=5 Participants	1480 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 78

Population: ITT was defined as all randomized participants who had received at least one dose of study treatment (Aducanumab or Placebo). 'Number of Participants Analyzed' signifies number of participants analyzed in this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo (PC Period) n=333 Participants Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 Low Dose (PC Period) n=331 Participants Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 High Dose (PC Period) n=295 Participants Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 78	1.56 score on a scale Standard Error 0.108	1.38 score on a scale Standard Error 0.108	1.59 score on a scale Standard Error 0.111

SECONDARY outcome

Timeframe: Baseline, Week 78

The MMSE is a widely used performance-based test of global cognitive status. It consists of 11 tasks that assess orientation, word recall, attention and calculation, language abilities, and visuospatial functions. The scores from the 11 tests are combined to obtain the total score, which ranges from 0 to 30, with lower scores over time indicating increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in MMSE. A negative change from baseline indicates clinical decline.

Outcome measures

Outcome measures
Measure	Placebo (PC Period) n=332 Participants Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 Low Dose (PC Period) n=334 Participants Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 High Dose (PC Period) n=297 Participants Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 78	-3.5 score on a scale Standard Error 0.21	-3.3 score on a scale Standard Error 0.21	-3.6 score on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline, Week 78

ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The scale items capture word recall, ability to follow commands, the ability to correctly copy or draw an image, naming, the ability to interact with everyday objects, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure for delayed word recall and concentration/distractibility. The total score ranges from 0 to 85. An increase in score over time indicates increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in ADAS-Cog 13. A positive change from baseline indicates clinical decline.

Outcome measures

Outcome measures
Measure	Placebo (PC Period) n=331 Participants Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 Low Dose (PC Period) n=332 Participants Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 High Dose (PC Period) n=294 Participants Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 Items) (ADAS-Cog 13) Score at Week 78	5.140 score on a scale Standard Error 0.3783	4.558 score on a scale Standard Error 0.3780	4.552 score on a scale Standard Error 0.3872

SECONDARY outcome

Timeframe: Baseline, Week 78

The ADCS-ADL-MCI consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the patient's actual functioning over the previous month and provide an assessment of change in the functional state of the participant over time. The total score ranges from 0 to 53, with lower values over time reflecting functional deterioration. MMRM analysis was used to analyze change from baseline in ADAS-ADL-MCI. A negative change from baseline indicates clinical decline.

Outcome measures

Outcome measures
Measure	Placebo (PC Period) n=331 Participants Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 Low Dose (PC Period) n=330 Participants Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 High Dose (PC Period) n=298 Participants Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL-MCI) Score at Week 78	-3.8 score on a scale Standard Error 0.35	-3.1 score on a scale Standard Error 0.35	-3.1 score on a scale Standard Error 0.35

Adverse Events

Placebo (PC Period)

Serious events: 70 serious events

Other events: 327 other events

Deaths: 0 deaths

BIIB037 Low Dose (PC Period)

Serious events: 76 serious events

Other events: 396 other events

Deaths: 3 deaths

BIIB037 High Dose (PC Period)

Serious events: 79 serious events

Other events: 410 other events

Deaths: 2 deaths

BIIB037 Late Start: Low Dose (LTE Period)

Serious events: 19 serious events

Other events: 89 other events

Deaths: 1 deaths

BIIB037 Late Start: High Dose (LTE Period)

Serious events: 14 serious events

Other events: 90 other events

Deaths: 1 deaths

BIIB037 Early Start: Low Dose (LTE Period)

Serious events: 35 serious events

Other events: 130 other events

Deaths: 1 deaths

BIIB037 Early Start: High Dose (LTE Period)

Serious events: 25 serious events

Other events: 121 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (PC Period) n=540 participants at risk Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 Low Dose (PC Period) n=549 participants at risk Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 High Dose (PC Period) n=558 participants at risk Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 Late Start: Low Dose (LTE Period) n=150 participants at risk Following PC period, participants randomized to placebo received BIIB037 low dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.	BIIB037 Late Start: High Dose (LTE Period) n=152 participants at risk Following PC period, participants randomized to placebo received BIIB037 high dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.	BIIB037 Early Start: Low Dose (LTE Period) n=299 participants at risk Following PC period, participants randomized to low dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.	BIIB037 Early Start: High Dose (LTE Period) n=251 participants at risk Following PC period, participants randomized to high dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia vera	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage 0	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Blood and lymphatic system disorders Leukocytosis	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Acute myocardial infarction	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 2/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Angina pectoris	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Arrhythmia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Atrial fibrillation	1.1% 6/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.73% 4/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.54% 3/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Atrial flutter	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Atrioventricular block	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Atrioventricular block complete	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Bradycardia	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Bundle branch block right	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Cardiac arrest	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Cardiac failure	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Cardiac failure congestive	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Coronary artery disease	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Coronary artery occlusion	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Coronary artery stenosis	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Mitral valve incompetence	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Myocardial infarction	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Myocardial ischaemia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Sinus bradycardia	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Sinus node dysfunction	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Supraventricular tachycardia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Cardiac disorders Tachycardia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Congenital, familial and genetic disorders Encephalocele	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Ear and labyrinth disorders Labyrinthine fistula	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Eye disorders Cataract	0.37% 2/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Eye disorders Diplopia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Eye disorders Retinal artery occlusion	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Abdominal distension	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Abdominal pain	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Constipation	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Duodenal ulcer	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Enteritis	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Gastritis	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Haemorrhoids	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Hiatus hernia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Ileus	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Inguinal hernia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.80% 2/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Intestinal perforation	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Large intestinal ulcer	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Large intestine perforation	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Large intestine polyp	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Mallory-weiss syndrome	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Melaena	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Pancreatic disorder	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
General disorders Asthenia	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
General disorders Chest pain	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	1.3% 2/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
General disorders Fatigue	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
General disorders Gait disturbance	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
General disorders General physical health deterioration	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
General disorders Incarcerated hernia	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
General disorders Non-cardiac chest pain	0.56% 3/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Hepatobiliary disorders Bile duct stone	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Hepatobiliary disorders Cholangitis acute	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Hepatobiliary disorders Cholecystitis	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Hepatobiliary disorders Cholecystitis acute	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Hepatobiliary disorders Cholelithiasis	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Appendicitis	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Appendicitis perforated	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Arthritis bacterial	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Arthritis infective	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Bronchitis	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Candida infection	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Cellulitis	0.37% 2/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Cholecystitis infective	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Diverticulitis	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Escherichia urinary tract infection	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Gastroenteritis	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Infection	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Influenza	0.37% 2/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Paronychia	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Pneumonia	0.37% 2/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.72% 4/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Pneumonia pneumococcal	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Post procedural infection	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Post procedural sepsis	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Postoperative wound infection	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Respiratory tract infection	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Sepsis	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Serratia infection	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Staphylococcal infection	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Subcutaneous abscess	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Urinary tract infection	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Urosepsis	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Wound infection staphylococcal	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.37% 2/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Concussion	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Exposure to toxic agent	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Fall	1.1% 6/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	2.2% 12/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.72% 4/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	2.7% 4/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	2.3% 7/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.80% 2/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Femoral neck fracture	0.37% 2/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Femur fracture	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Foot fracture	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Hand fracture	0.37% 2/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Heat illness	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 2/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Limb crushing injury	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Overdose	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Post procedural complication	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Postoperative respiratory failure	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Road traffic accident	0.37% 2/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Scapula fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Skull fracture	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Spinal fracture	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Subdural haematoma	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Subdural haemorrhage	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Thermal burn	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Upper limb fracture	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Investigations Blood ketone body increased	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Investigations Blood pressure increased	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Metabolism and nutrition disorders Dehydration	0.37% 2/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Metabolism and nutrition disorders Gout	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Metabolism and nutrition disorders Hypoglycaemia	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Musculoskeletal and connective tissue disorders Bone pain	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 2/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Musculoskeletal and connective tissue disorders Vertebral osteophyte	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage i	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive papillary breast carcinoma	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.37% 2/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative neoplasm	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurofibrosarcoma	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer stage iii	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tubular breast carcinoma	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Amyloid related imaging abnormality-oedema/effusion	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	1.3% 7/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	1.3% 2/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	1.3% 2/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Balance disorder	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Carotid artery stenosis	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Cerebral haematoma	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Cerebral haemorrhage	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Cerebral infarction	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Cerebral ischaemia	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Cerebrovascular accident	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Dementia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Dementia alzheimer's type	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Dementia with lewy bodies	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Dysarthria	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Dystonia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Focal dyscognitive seizures	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Haemorrhage intracranial	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Head discomfort	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Headache	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.80% 2/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Hypoaesthesia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Ischaemic stroke	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Lacunar infarction	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Lacunar stroke	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Loss of consciousness	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Migraine	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Myasthenia gravis	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Myelitis transverse	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Myoclonus	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Nervous system disorder	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Orthostatic intolerance	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Parkinson's disease	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Partial seizures	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Peroneal nerve palsy	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Presyncope	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Seizure	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Subarachnoid haemorrhage	0.37% 2/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Superficial siderosis of central nervous system	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Syncope	0.37% 2/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.73% 4/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.90% 5/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 2/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Transient ischaemic attack	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Vertebral artery dissection	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Psychiatric disorders Agitation	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Psychiatric disorders Anxiety	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Psychiatric disorders Completed suicide	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Psychiatric disorders Delirium	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Psychiatric disorders Depression	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Psychiatric disorders Generalised anxiety disorder	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Psychiatric disorders Mental status changes	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Psychiatric disorders Persistent depressive disorder	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Psychiatric disorders Psychogenic tremor	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Psychiatric disorders Psychotic disorder	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Psychiatric disorders Suicide attempt	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.36% 2/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Renal and urinary disorders Acute kidney injury	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Renal and urinary disorders Nephrolithiasis	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Renal and urinary disorders Renal colic	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Renal and urinary disorders Ureterolithiasis	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Renal and urinary disorders Urinary retention	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Reproductive system and breast disorders Prostatic dysplasia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.66% 1/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 2/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.37% 2/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.54% 3/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Vascular disorders Aortic aneurysm	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Vascular disorders Aortic dissection	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Vascular disorders Aortic stenosis	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Vascular disorders Deep vein thrombosis	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.72% 4/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Vascular disorders Hypertension	0.19% 1/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Vascular disorders Hypertensive emergency	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Vascular disorders Hypotension	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.67% 1/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.40% 1/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Vascular disorders Orthostatic hypotension	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.33% 1/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Vascular disorders Peripheral artery stenosis	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.18% 1/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.

Other adverse events

Other adverse events
Measure	Placebo (PC Period) n=540 participants at risk Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 Low Dose (PC Period) n=549 participants at risk Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 High Dose (PC Period) n=558 participants at risk Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.	BIIB037 Late Start: Low Dose (LTE Period) n=150 participants at risk Following PC period, participants randomized to placebo received BIIB037 low dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.	BIIB037 Late Start: High Dose (LTE Period) n=152 participants at risk Following PC period, participants randomized to placebo received BIIB037 high dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.	BIIB037 Early Start: Low Dose (LTE Period) n=299 participants at risk Following PC period, participants randomized to low dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.	BIIB037 Early Start: High Dose (LTE Period) n=251 participants at risk Following PC period, participants randomized to high dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
Gastrointestinal disorders Diarrhoea	8.1% 44/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	8.9% 49/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	9.3% 52/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	4.0% 6/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.3% 8/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.4% 16/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	3.6% 9/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Gastrointestinal disorders Nausea	7.8% 42/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.5% 30/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	7.2% 40/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	3.3% 5/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	6.6% 10/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	4.3% 13/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	2.4% 6/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
General disorders Fatigue	7.0% 38/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.5% 30/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	6.1% 34/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Nasopharyngitis	11.9% 64/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	11.8% 65/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	12.2% 68/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	7.3% 11/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	7.2% 11/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	6.7% 20/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	6.0% 15/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Upper respiratory tract infection	9.1% 49/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	8.6% 47/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	9.1% 51/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	6.7% 10/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	7.9% 12/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	7.0% 21/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	8.0% 20/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Infections and infestations Urinary tract infection	6.9% 37/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.5% 30/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	6.1% 34/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	8.0% 12/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	3.3% 5/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.4% 16/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.6% 14/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Contusion	4.3% 23/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	6.0% 33/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	6.5% 36/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	2.7% 4/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	3.9% 6/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.7% 17/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	1.6% 4/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Injury, poisoning and procedural complications Fall	10.0% 54/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	12.8% 70/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	14.9% 83/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	7.3% 11/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	11.8% 18/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	9.4% 28/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	8.8% 22/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Musculoskeletal and connective tissue disorders Arthralgia	5.2% 28/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	4.9% 27/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	6.3% 35/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Musculoskeletal and connective tissue disorders Back pain	7.8% 42/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	4.7% 26/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	7.9% 44/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits	6.3% 34/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	16.2% 89/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	18.3% 102/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	15.3% 23/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	14.5% 22/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.4% 16/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	7.2% 18/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Amyloid related imaging abnormality-oedema/effusion	3.0% 16/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	25.5% 140/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	34.9% 195/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	22.0% 33/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	28.3% 43/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	6.4% 19/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	8.4% 21/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Dizziness	10.0% 54/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	8.9% 49/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	9.7% 54/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	4.0% 6/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	2.6% 4/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	4.7% 14/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.2% 13/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Headache	15.0% 81/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	17.9% 98/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	20.6% 115/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	9.3% 14/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	12.5% 19/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	9.0% 27/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	9.6% 24/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Nervous system disorders Superficial siderosis of central nervous system	1.9% 10/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	9.3% 51/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	15.8% 88/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	10.0% 15/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	11.2% 17/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	3.0% 9/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.6% 14/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Psychiatric disorders Anxiety	5.2% 28/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.8% 32/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.0% 28/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	4.7% 7/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	2.6% 4/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	4.0% 12/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.6% 14/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Psychiatric disorders Depression	6.3% 34/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	7.3% 40/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	6.1% 34/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.3% 8/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	3.3% 5/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	3.0% 9/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	3.6% 9/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Respiratory, thoracic and mediastinal disorders Cough	6.1% 33/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.3% 29/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	3.4% 19/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	6.0% 9/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	2.6% 4/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	4.0% 12/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	2.4% 6/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
Psychiatric disorders Confusional state	0.00% 0/540 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/549 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	0.00% 0/558 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	3.3% 5/150 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	5.9% 9/152 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	1.3% 4/299 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.	1.2% 3/251 • From First Dose to End of Study (up to 4 years) Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.

Additional Information

Biogen Study Medical Director

Biogen

Phone: 866-633-4636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Publication restrictions are in place

Restriction type: OTHER