Trial Outcomes & Findings for A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents (NCT NCT01444430)

NCT ID: NCT01444430

Last Updated: 2016-12-15

Results Overview

Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 12460 participants
• Primary outcome timeframe: Up to 27 weeks
• Results posted on: 2016-12-15

Participant Flow

This study started with an assessment visit where inclusion/exclusion criteria were reviewed and informed consent obtained. Eligible patients were randomized at the next visit. Patients then entered a 26 weeks double-blind treatment period followed by a 1 week follow-up telephone contact. Patients were recruited in 25 countries with 25% in the US.

Eligible adult and adolescent patients were stratified based upon assessment of ACQ and prior asthma therapy and randomized 1:1 to double-blind Symbicort or budesonide. 12460 patients were enrolled (informed consent received) and 11693 were randomized.

Participant milestones

Measure	Symbicort Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).	Budesonide Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Overall Study STARTED	5846	5847
Overall Study COMPLETED	5785	5766
Overall Study NOT COMPLETED	61	81

Reasons for withdrawal

Measure	Symbicort Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).	Budesonide Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Overall Study Withdrawal by Subject	53	72
Overall Study Death	6	8
Overall Study Lost to Follow-up	2	0
Overall Study CRF termination module not completed.	0	1

Baseline Characteristics

A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents

Baseline characteristics by cohort

Measure	Symbicort n=5846 Participants Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).	Budesonide n=5847 Participants Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).	Total n=11693 Participants Total of all reporting groups
Age, Continuous	43.4 Years STANDARD_DEVIATION 17.4 • n=5 Participants	43.5 Years STANDARD_DEVIATION 17.3 • n=7 Participants	43.5 Years STANDARD_DEVIATION 17.3 • n=5 Participants
Gender Female	3849 Participants n=5 Participants	3820 Participants n=7 Participants	7669 Participants n=5 Participants
Gender Male	1997 Participants n=5 Participants	2027 Participants n=7 Participants	4024 Participants n=5 Participants
Race/Ethnicity, Customized White	4050 Participants n=5 Participants	4003 Participants n=7 Participants	8053 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	396 Participants n=5 Participants	401 Participants n=7 Participants	797 Participants n=5 Participants
Race/Ethnicity, Customized Asian	848 Participants n=5 Participants	907 Participants n=7 Participants	1755 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islander	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	225 Participants n=5 Participants	207 Participants n=7 Participants	432 Participants n=5 Participants
Race/Ethnicity, Customized Other	324 Participants n=5 Participants	326 Participants n=7 Participants	650 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 27 weeks

Population: Full analysis set (FAS) population comprised of all patients randomized to study drug.

Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.

Outcome measures

Measure	Symbicort n=5846 Participants Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).	Budesonide n=5847 Participants Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)	43 Participants	40 Participants

PRIMARY outcome

Timeframe: Up to 26 weeks

Population: The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient's period of exposure to study drug plus 7 days after the last date of study drug treatment.

Number of participants experiencing an event included in the definition of asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.

Outcome measures

Measure	Symbicort n=5846 Participants Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).	Budesonide n=5847 Participants Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation	539 Participants	633 Participants

SECONDARY outcome

Timeframe: Daily up to 26 weeks

Population: Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.

Percent of days with no asthma symptoms during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.

Outcome measures

Measure	Symbicort n=5784 Participants Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).	Budesonide n=5796 Participants Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Percent of Days With no Asthma Symptoms	81.1 Percentage of days Standard Error 0.4	76.8 Percentage of days Standard Error 0.4

SECONDARY outcome

Timeframe: Daily up to 26 weeks

Population: Full analysis set (FAS) population comprised of all patients randomized to study drug. The analysis set comprises of all patients with at least one day with asthma symptoms, i.e. the denominator is the number of days with asthma symptoms.

Percent of days with activity limitation due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.

Outcome measures

Measure	Symbicort n=4895 Participants Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).	Budesonide n=5045 Participants Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Percent of Days With Activity Limitation Due to Asthma	19.7 Percentage of days Standard Error 0.4	19.1 Percentage of days Standard Error 0.4

SECONDARY outcome

Timeframe: Daily up to 26 weeks

Population: Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.

Mean number of puffs of rescue medication per day (24 hours) during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.

Outcome measures

Measure	Symbicort n=5784 Participants Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).	Budesonide n=5796 Participants Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Mean Number of Puffs of Rescue Medication Per 24 Hours	0.8 Inhalations/day Standard Error 0.0	0.9 Inhalations/day Standard Error 0.0

SECONDARY outcome

Timeframe: baseline, day 28, day 84, day 182

Population: Full analysis set (FAS) population comprised of all patients randomized to study drug with at least one post-baseline ACQ6 score.

The outcome variable for ACQ6 was the difference between the average of values recorded during the treatment period (day 28, day 84 and day 182) and the baseline measure. Analysis of covariance (ANCOVA) model, including the fixed factors of treatment and strata by incoming control/asthma treatment and baseline ACQ6 as covariate was used to compare Symbicort and budesonide.

The asthma control questionnaire, ACQ6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions.

Outcome measures

Measure	Symbicort n=5701 Participants Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).	Budesonide n=5698 Participants Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Asthma Control Questionnaire (ACQ6)	-0.70 ACQ6 overall score change from baseline Standard Error 0.01	-0.62 ACQ6 overall score change from baseline Standard Error 0.01

SECONDARY outcome

Timeframe: Daily up to 26 weeks

Population: Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.

Percent of nights with awakening(s) due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.

Outcome measures

Measure	Symbicort n=5784 Participants Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).	Budesonide n=5796 Participants Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Percent of Nights With Awakening(s) Due to Asthma	4.0 Percentage of nights Standard Error 0.2	4.7 Percentage of nights Standard Error 0.2

SECONDARY outcome

Timeframe: Up to 26 weeks

Population: The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient's period of exposure to study drug plus 7 days after the last date of study drug treatment.

Number of participants experiencing discontinuation of investigational product due to a protocol defined asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.

Outcome measures

Measure	Symbicort n=5846 Participants Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).	Budesonide n=5847 Participants Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation	53 Participants	71 Participants

Adverse Events

Symbicort

Serious events: 125 serious events

Other events: 0 other events

Deaths: 0 deaths

Budesonide

Serious events: 123 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Symbicort n=5846 participants at risk Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).	Budesonide n=5847 participants at risk Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Acute myocardial infarction	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Angina pectoris	0.05% 3/5846 • Number of events 3 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Angina unstable	0.03% 2/5846 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Arrhythmia	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Atrial fibrillation	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.05% 3/5847 • Number of events 3 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Atrial flutter	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Cardiac failure chronic	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Cardiac failure congestive	0.03% 2/5846 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Cardiopulmonary failure	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Coronary artery disease	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Coronary artery insufficiency	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Hypertensive heart disease	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Mitral valve stenosis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Myocardial infarction	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Myocardial ischaemia	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Myocarditis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Supraventricular tachycardia	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Cardiac disorders Tachycardia	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.03% 2/5847 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Ear and labyrinth disorders Vertigo	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Abdominal hernia	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Abdominal pain	0.03% 2/5846 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.03% 2/5847 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.05% 3/5847 • Number of events 3 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Colitis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Colitis ulcerative	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Diarrhoea	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Dyspepsia	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Erosive oesophagitis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Food poisoning	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Gastritis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.03% 2/5846 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.03% 2/5847 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Haematochezia	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Haemorrhoids	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Hiatus hernia	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Inguinal hernia	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Intussusception	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Oesophagitis haemorrhagic	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Pancreatitis acute	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Peritoneal haemorrhage	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Gastrointestinal disorders Umbilical hernia	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
General disorders Chest pain	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
General disorders Death	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
General disorders Device dislocation	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
General disorders Influenza like illness	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
General disorders Non-cardiac chest pain	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.03% 2/5847 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Hepatobiliary disorders Biliary colic	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Hepatobiliary disorders Biliary dyskinesia	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Hepatobiliary disorders Cholecystitis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Hepatobiliary disorders Cholelithiasis	0.03% 2/5846 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Hepatobiliary disorders Hepatitis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Immune system disorders Allergic granulomatous angiitis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Immune system disorders Anaphylactic reaction	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Immune system disorders Anaphylactic shock	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Immune system disorders Hypersensitivity	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Abdominal abscess	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Acute sinusitis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Appendicitis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Bronchitis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Bronchitis bacterial	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Cellulitis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Clostridium difficile infection	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Cystitis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Diarrhoea infectious	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Dysentery	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Gastroenteritis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Gastroenteritis norovirus	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Haemophilus infection	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Herpes zoster	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Influenza	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.03% 2/5847 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Lower respiratory tract infection bacterial	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Malaria	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Mycoplasma infection	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Nasopharyngitis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Osteomyelitis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Pharyngitis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Pharyngotonsillitis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Pneumonia	0.21% 12/5846 • Number of events 12 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.10% 6/5847 • Number of events 6 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Pneumonia bacterial	0.03% 2/5846 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.05% 3/5847 • Number of events 3 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Postoperative wound infection	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Rhinitis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Sepsis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Sinusitis	0.03% 2/5846 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Tuberculous pleurisy	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Infections and infestations Upper respiratory tract infection bacterial	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.03% 2/5847 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Ankle fracture	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Burns first degree	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Burns second degree	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Contusion	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Electric shock	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Muscle strain	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Rib fracture	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Road traffic accident	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Injury, poisoning and procedural complications Wound	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Investigations Blood pressure increased	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Investigations Heart rate irregular	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Metabolism and nutrition disorders Dehydration	0.03% 2/5846 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Metabolism and nutrition disorders Hyperosmolar hyperglycaemic state	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Metabolism and nutrition disorders Obesity	0.03% 2/5846 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Musculoskeletal and connective tissue disorders Back pain	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.02% 1/5846 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.05% 3/5847 • Number of events 3 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.03% 2/5847 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Astrocytoma malignant	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian germ cell teratoma benign	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.03% 2/5846 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Nervous system disorders Cerebral haematoma	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Nervous system disorders Cerebral infarction	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Nervous system disorders Cerebrospinal fluid leakage	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Nervous system disorders Cerebrovascular accident	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.05% 3/5847 • Number of events 4 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Nervous system disorders Cerebrovascular disorder	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Nervous system disorders Hypoaesthesia	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Nervous system disorders Monoparesis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Nervous system disorders Seizure	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Nervous system disorders Syncope	0.05% 3/5846 • Number of events 3 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Psychiatric disorders Aggression	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Psychiatric disorders Bipolar I disorder	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Psychiatric disorders Completed suicide	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Psychiatric disorders Depression	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Psychiatric disorders Stress	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Psychiatric disorders Suicide attempt	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Renal and urinary disorders Acute kidney injury	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Renal and urinary disorders Hydronephrosis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Renal and urinary disorders Nephritis	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Renal and urinary disorders Nephrolithiasis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Renal and urinary disorders Pelvi-ureteric obstruction	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Renal and urinary disorders Urinary tract infection	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Reproductive system and breast disorders Menometrorrhagia	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Reproductive system and breast disorders Ovarian cyst	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Reproductive system and breast disorders Pelvic prolapse	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Respiratory, thoracic and mediastinal disorders Asthma	0.60% 35/5846 • Number of events 38 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.62% 36/5847 • Number of events 39 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Respiratory, thoracic and mediastinal disorders Cough	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.03% 2/5847 • Number of events 2 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Respiratory, thoracic and mediastinal disorders Vocal cord disorder	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Vascular disorders Deep vein thrombosis	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Vascular disorders Haematoma	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Vascular disorders Hypertension	0.00% 0/5846 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.02% 1/5847 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.
Vascular disorders Venous thrombosis limb	0.02% 1/5846 • Number of events 1 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.	0.00% 0/5847 • Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks. AEs were not collected unless they lead to discontinuation or qualified as an SAE.

Other adverse events

Adverse event data not reported

Additional Information

Carin Jorup, Global Clinical Lead (GCL) SYMBICORT

AstraZeneca Research and Development

Phone: +46 31 7761000

Email: Carin.Jorup@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee ≥ 60 days prior to submission of material for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ's Confidential Information without AZ's written approval. AZ can request Inst. and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication or presentation.
• Publication restrictions are in place

Restriction type: OTHER