Trial Outcomes & Findings for Randomized, Placebo-Controlled, Multidose, Study Comparing Generic Budesonide/Formoterol Fumarate Dihydrate to Symbicort® in Asthmatic Participants (NCT NCT02495168)

NCT ID: NCT02495168

Last Updated: 2019-11-29

Results Overview

FEV1 was measured using spirometry in accordance with the ATS/ERS consensus guidelines. Baseline-adjusted area under the serial FEV1-time curve was calculated from Time 0 to 12 hours on the first day of the Treatment Period (Day 1). FEV1 AUC0-12 was calculated from baseline-adjusted values using the linear trapezoidal method. The calculation assumed that at time of dosing (Time 0) the baseline adjusted FEV1 was also 0. The calculation proceeded over all available post-dose FEV1 assessments on Day 1 (including unscheduled time points, if any) using actual elapsed time from dosing. FEV1 baseline defined as the average of predose FEV1 values obtained on Day 1. If some of these values were missing, the average was calculated using the available values, however, a minimum of 2 predose FEV1 values were required; participants who had only 1 or no predose FEV1 measurements on Day 1 would have their FEV1 baseline missing, and the participant was to be excluded from analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1714 participants
• Primary outcome timeframe: 0 to 12 hours on Day 1
• Results posted on: 2019-11-29

Participant Flow

Participants (N=1714) were provided a generic placebo pressurized metered dose inhaler (pMDI) device for use during a 2-week Run-in Period for device training. Then, qualified participants (N=1147) were randomly assigned to treatment on a 4:4:1 ratio of generic budesonide/formoterol fumarate dihydrate, Symbicort, or Placebo, respectively.

Participant milestones

Measure	Generic Budesonide/Formoterol Fumarate Dihydrate After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic budesonide/formoterol fumarate dihydrate (80 microgram \[μg\]/4.5 μg) pMDI for up to 50 days.	Symbicort (Budesonide/Formoterol Fumarate Dihydrate) After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a Symbicort budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.	Placebo After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic placebo pMDI for up to 50 days.
Overall Study STARTED	504	516	127
Overall Study Safety Population	501	514	126
Overall Study Modified Intent-to-Treat Population	468	478	111
Overall Study Day1 Per-protocol Set (D1PPS) Population	437	437	99
Overall Study Day 42 (D42PPS) Population	382	383	88
Overall Study COMPLETED	466	462	110
Overall Study NOT COMPLETED	38	54	17

Reasons for withdrawal

Measure	Generic Budesonide/Formoterol Fumarate Dihydrate After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic budesonide/formoterol fumarate dihydrate (80 microgram \[μg\]/4.5 μg) pMDI for up to 50 days.	Symbicort (Budesonide/Formoterol Fumarate Dihydrate) After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a Symbicort budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.	Placebo After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic placebo pMDI for up to 50 days.
Overall Study Other than Specified	18	22	5
Overall Study Did not Complete Final Visit On Time	4	3	2
Overall Study Physician Decision	1	1	0
Overall Study Lost to Follow-up	10	6	1
Overall Study Withdrawal by Subject	1	4	2
Overall Study Protocol Violation	0	10	1
Overall Study Adverse Event	4	8	3
Overall Study Lack of Efficacy	0	0	3

Baseline Characteristics

Participants who received at least 1 dose of study drug, no major inclusion/exclusion violations, and enrolled in the study only once (Modified Intent-to-Treat [mITT] Population) and with evaluable FEV1 data.

Baseline characteristics by cohort

Measure	Generic Budesonide/Formoterol Fumarate Dihydrate n=501 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.	Symbicort (Budesonide/Formoterol Fumarate Dihydrate) n=514 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a Symbicort budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.	Placebo n=126 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic placebo pMDI for up to 50 days.	Total n=1141 Participants Total of all reporting groups
Age, Continuous	42.7 years STANDARD_DEVIATION 15.39 • n=501 Participants	43.9 years STANDARD_DEVIATION 15.56 • n=514 Participants	41.5 years STANDARD_DEVIATION 15.88 • n=126 Participants	43.1 years STANDARD_DEVIATION 15.53 • n=1141 Participants
Sex: Female, Male Female	299 Participants n=501 Participants	292 Participants n=514 Participants	70 Participants n=126 Participants	661 Participants n=1141 Participants
Sex: Female, Male Male	202 Participants n=501 Participants	222 Participants n=514 Participants	56 Participants n=126 Participants	480 Participants n=1141 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	171 Participants n=501 Participants	180 Participants n=514 Participants	48 Participants n=126 Participants	399 Participants n=1141 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	330 Participants n=501 Participants	334 Participants n=514 Participants	78 Participants n=126 Participants	742 Participants n=1141 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=501 Participants	0 Participants n=514 Participants	0 Participants n=126 Participants	0 Participants n=1141 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=501 Participants	2 Participants n=514 Participants	0 Participants n=126 Participants	2 Participants n=1141 Participants
Race (NIH/OMB) Asian	9 Participants n=501 Participants	11 Participants n=514 Participants	5 Participants n=126 Participants	25 Participants n=1141 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=501 Participants	2 Participants n=514 Participants	0 Participants n=126 Participants	2 Participants n=1141 Participants
Race (NIH/OMB) Black or African American	90 Participants n=501 Participants	86 Participants n=514 Participants	23 Participants n=126 Participants	199 Participants n=1141 Participants
Race (NIH/OMB) White	402 Participants n=501 Participants	410 Participants n=514 Participants	97 Participants n=126 Participants	909 Participants n=1141 Participants
Race (NIH/OMB) More than one race	0 Participants n=501 Participants	3 Participants n=514 Participants	1 Participants n=126 Participants	4 Participants n=1141 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=501 Participants	0 Participants n=514 Participants	0 Participants n=126 Participants	0 Participants n=1141 Participants
Forced Expiratory Volume in 1 Second (FEV1)	2.113 liters STANDARD_DEVIATION 0.5524 • n=466 Participants • Participants who received at least 1 dose of study drug, no major inclusion/exclusion violations, and enrolled in the study only once (Modified Intent-to-Treat \[mITT\] Population) and with evaluable FEV1 data.	2.083 liters STANDARD_DEVIATION 0.5400 • n=476 Participants • Participants who received at least 1 dose of study drug, no major inclusion/exclusion violations, and enrolled in the study only once (Modified Intent-to-Treat \[mITT\] Population) and with evaluable FEV1 data.	2.136 liters STANDARD_DEVIATION 0.5975 • n=111 Participants • Participants who received at least 1 dose of study drug, no major inclusion/exclusion violations, and enrolled in the study only once (Modified Intent-to-Treat \[mITT\] Population) and with evaluable FEV1 data.	2.102 liters STANDARD_DEVIATION 0.5515 • n=1053 Participants • Participants who received at least 1 dose of study drug, no major inclusion/exclusion violations, and enrolled in the study only once (Modified Intent-to-Treat \[mITT\] Population) and with evaluable FEV1 data.

PRIMARY outcome

Timeframe: 0 to 12 hours on Day 1

Population: Randomized participants who received at least 1 dose of study drug, no major inclusion/exclusion violations, enrolled in the study only once, and no major protocol violations that impacted analysis of the Day 1 FEV1 AUC (D1PPS Population).

FEV1 was measured using spirometry in accordance with the ATS/ERS consensus guidelines. Baseline-adjusted area under the serial FEV1-time curve was calculated from Time 0 to 12 hours on the first day of the Treatment Period (Day 1). FEV1 AUC0-12 was calculated from baseline-adjusted values using the linear trapezoidal method. The calculation assumed that at time of dosing (Time 0) the baseline adjusted FEV1 was also 0. The calculation proceeded over all available post-dose FEV1 assessments on Day 1 (including unscheduled time points, if any) using actual elapsed time from dosing. FEV1 baseline defined as the average of predose FEV1 values obtained on Day 1. If some of these values were missing, the average was calculated using the available values, however, a minimum of 2 predose FEV1 values were required; participants who had only 1 or no predose FEV1 measurements on Day 1 would have their FEV1 baseline missing, and the participant was to be excluded from analysis.

Outcome measures

Measure	Symbicort (Budesonide/Formoterol Fumarate Dihydrate) n=437 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a Symbicort budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.	Placebo n=99 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic placebo pMDI for up to 50 days.	Generic Budesonide/Formoterol Fumarate Dihydrate n=437 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.
Equivalence Analysis of Area Under the Serial FEV1-Time Effect Curve From Time 0 to 12 Hours (FEV1 Area Under Curve [AUC0-12]) on the First Day of Treatment	3.584 Liter*hour (Lh) Standard Deviation 2.9913	1.460 Liter*hour (Lh) Standard Deviation 3.3183	3.637 Liter*hour (Lh) Standard Deviation 3.2532

PRIMARY outcome

Timeframe: 0 to 12 hours on Day 1

Population: Randomized participants who received at least 1 dose of study drug, no major inclusion/exclusion violations, and enrolled in the study only once (mITT Population) and with evaluable FEV1 AUC data.

FEV1 was measured using spirometry in accordance with the ATS/ERS consensus guidelines. Baseline-adjusted area under the serial FEV1-time curve was calculated from Time 0 to 12 hours on the first day of the Treatment Period (Day 1). FEV1 AUC0-12 was calculated from baseline-adjusted values using the linear trapezoidal method. The calculation assumed that at time of dosing (Time 0) the baseline adjusted FEV1 was also 0. The calculation proceeded over all available post-dose FEV1 assessments on Day 1 (including unscheduled time points, if any) using actual elapsed time from dosing. FEV1 baseline defined as the average of predose FEV1 values obtained on Day 1. If some of these values were missing, the average was calculated using the available values, however, a minimum of 2 predose FEV1 values were required; participants who had only 1 or no predose FEV1 measurements on Day 1 would have their FEV1 baseline missing, and the participant was to be excluded from analysis.

Outcome measures

Measure	Symbicort (Budesonide/Formoterol Fumarate Dihydrate) n=478 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a Symbicort budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.	Placebo n=111 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic placebo pMDI for up to 50 days.	Generic Budesonide/Formoterol Fumarate Dihydrate n=468 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.
Superiority Analysis of Area Under the Serial FEV1-Time Effect Curve From Time 0 to 12 Hours (FEV AUC0-12) on the First Day of Treatment	3.573 Lh Standard Deviation 2.9960	1.449 Lh Standard Deviation 3.3033	3.630 Lh Standard Deviation 3.2528

PRIMARY outcome

Timeframe: Day 1 up to Day 50

Population: Randomized participants who received at least 1 dose of study drug, no major inclusion/exclusion violations, enrolled in the study only once, and no major protocol violations that impacted analysis of the Day 42 FEV1 AUC (D42PPS Population).

FEV1 was measured using spirometry in accordance with the ATS/ERS consensus guidelines. Average predose FEV1 at End of Treatment defined as the average of all predose assessments on Day 42. If a participant had no predose assessment on Day 42, the average of all available predose assessments on the last day (for example, Early Termination visit [up to Day 50]) when at least 1 predose FEV1 assessments was available was imputed, if the participant discontinued due to lack of efficacy, otherwise there was no imputation. Baseline was defined as the average of at least 2 predose FEV1 values obtained on Day 1. The endpoint of baseline-adjusted predose FEV1 at end of treatment was calculated as follows: [FEV1 at end of treatment] - [Baseline FEV1].

Outcome measures

Measure	Symbicort (Budesonide/Formoterol Fumarate Dihydrate) n=383 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a Symbicort budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.	Placebo n=88 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic placebo pMDI for up to 50 days.	Generic Budesonide/Formoterol Fumarate Dihydrate n=382 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.
Equivalence Analysis of Baseline-Adjusted Average Predose FEV1 at End of Treatment	0.283 liters Standard Deviation 0.3241	0.094 liters Standard Deviation 0.3298	0.278 liters Standard Deviation 0.3306

PRIMARY outcome

Timeframe: Day 1 up to Day 50

Population: Randomized participants who received at least 1 dose of study drug, no major inclusion/exclusion violations, and enrolled in the study only once (mITT Population) and with evaluable baseline-adjusted average predose FEV1 data.

FEV1 was measured using spirometry in accordance with the ATS/ERS consensus guidelines. Average predose FEV1 at End of Treatment defined as the average of all predose assessments on Day 42. If a participant had no predose assessment on Day 42, the average of all available predose assessments on the last day (for example, Early Termination visit [up to Day 50]) when at least 1 predose FEV1 assessments was available was imputed, if the participant discontinued due to lack of efficacy, otherwise there was no imputation. Baseline was defined as the average of at least 2 predose FEV1 values obtained on Day 1. The endpoint of baseline-adjusted predose FEV1 at end of treatment was calculated as follows: [FEV1 at end of treatment] - [Baseline FEV1].

Outcome measures

Measure	Symbicort (Budesonide/Formoterol Fumarate Dihydrate) n=478 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a Symbicort budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.	Placebo n=111 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic placebo pMDI for up to 50 days.	Generic Budesonide/Formoterol Fumarate Dihydrate n=468 Participants After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.
Superiority Analysis of Baseline-Adjusted Average Predose FEV1 at End of Treatment	0.277 liters Standard Deviation 0.3156	0.124 liters Standard Deviation 0.3673	0.269 liters Standard Deviation 0.3238

Adverse Events

Generic Budesonide/Formoterol Fumarate Dihydrate

Serious events: 3 serious events

Other events: 70 other events

Deaths: 0 deaths

Symbicort (Budesonide/Formoterol Fumarate Dihydrate)

Serious events: 2 serious events

Other events: 79 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Generic Budesonide/Formoterol Fumarate Dihydrate n=501 participants at risk After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.	Symbicort (Budesonide/Formoterol Fumarate Dihydrate) n=514 participants at risk After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a Symbicort budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.	Placebo n=126 participants at risk After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic placebo pMDI for up to 50 days.
Blood and lymphatic system disorders Anaemia	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.79% 1/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Cardiac disorders Atrial fibrillation	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
General disorders Non-cardiac chest pain	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Upper respiratory tract infection	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.33% 1/299 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/292 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/70 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Vascular disorders Hypertensive crisis	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).

Other adverse events

Measure	Generic Budesonide/Formoterol Fumarate Dihydrate n=501 participants at risk After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.	Symbicort (Budesonide/Formoterol Fumarate Dihydrate) n=514 participants at risk After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a Symbicort budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days.	Placebo n=126 participants at risk After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants administered 2 inhalations twice daily via a generic placebo pMDI for up to 50 days.
Renal and urinary disorders Glycosuria	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Renal and urinary disorders Haematuria	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Renal and urinary disorders Hydronephrosis	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.79% 1/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Respiratory, thoracic and mediastinal disorders Cough	0.40% 2/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.39% 2/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Renal and urinary disorders Nephrolithiasis	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Sinusitis	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.97% 5/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.79% 1/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Upper respiratory tract infection	2.4% 12/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	1.6% 8/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	2.4% 3/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Viral upper respiratory tract infection	2.0% 10/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.97% 5/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.79% 1/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	1.2% 6/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Nervous system disorders Headache	1.00% 5/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	2.1% 11/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	2.4% 3/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Respiratory, thoracic and mediastinal disorders Asthma	0.60% 3/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.78% 4/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	1.6% 2/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.60% 3/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.97% 5/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Cardiac disorders Angina pectoris	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Cardiac disorders Palpitations	0.40% 2/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Eye disorders Blepharitis	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Gastrointestinal disorders Abdominal distension	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Gastrointestinal disorders Abdominal pain	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Gastrointestinal disorders Abdominal pain upper	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Gastrointestinal disorders Diarrhoea	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.40% 2/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Gastrointestinal disorders Haematochezia	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Gastrointestinal disorders Inguinal hernia	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Gastrointestinal disorders Nausea	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Gastrointestinal disorders Toothache	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Gastrointestinal disorders Vomiting	0.40% 2/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
General disorders Adverse drug reaction	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
General disorders Asthenia	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
General disorders Chest discomfort	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
General disorders Hernia pain	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
General disorders Malaise	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
General disorders Pain	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.39% 2/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Immune system disorders Hypersensitivity	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Acute sinusitis	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Body tinea	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Bronchitis	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Folliculitis	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Gastroenteritis	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.39% 2/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.79% 1/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Herpes zoster	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Hordeolum	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Influenza	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.39% 2/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Laryngitis	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Otitis externa	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Pharyngitis	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.39% 2/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Respiratory tract infection	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Tooth abscess	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Tooth infection	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Urinary tract infection	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Viral infection	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Viral pharyngitis	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Infections and infestations Vulvovaginal mycotic infection	0.33% 1/299 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/292 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/70 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Injury, poisoning and procedural complications Arthropod sting	0.40% 2/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Injury, poisoning and procedural complications Foot fracture	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Injury, poisoning and procedural complications Laceration	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.39% 2/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Injury, poisoning and procedural complications Neck injury	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Investigations Alanine aminotransferase increased	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Investigations Antinuclear antibody positive	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Investigations Aspartate aminotransferase increased	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Investigations Blood glucose decreased	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Investigations Blood glucose increased	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Investigations Blood potassium increased	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Investigations Glucose urine	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Investigations Glucose urine present	0.40% 2/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Investigations Liver function test increased	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Investigations Protein urine present	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Metabolism and nutrition disorders Hypercholesterolaemia	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.79% 1/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Metabolism and nutrition disorders Increased appetite	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Metabolism and nutrition disorders Lactic acidosis	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Musculoskeletal and connective tissue disorders Arthritis	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Musculoskeletal and connective tissue disorders Muscle spasms	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.79% 1/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.39% 2/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.79% 1/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Musculoskeletal and connective tissue disorders Tendonitis	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Nervous system disorders Dizziness	0.40% 2/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Nervous system disorders Hypoaesthesia	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Nervous system disorders Migraine	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Nervous system disorders Paraesthesia	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Nervous system disorders Sciatica	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Nervous system disorders Sinus headache	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Nervous system disorders Syncope	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Psychiatric disorders Insomnia	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Psychiatric disorders Mood swings	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.39% 2/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.40% 2/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Respiratory, thoracic and mediastinal disorders Wheezing	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Skin and subcutaneous tissue disorders Dermatitis contact	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Skin and subcutaneous tissue disorders Pruritus	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Skin and subcutaneous tissue disorders Rash	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.39% 2/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Skin and subcutaneous tissue disorders Rash erythematous	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Skin and subcutaneous tissue disorders Urticaria	0.20% 1/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Surgical and medical procedures Bunion operation	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Surgical and medical procedures Tooth extraction	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.19% 1/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).
Vascular disorders Hypertension	0.00% 0/501 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.39% 2/514 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).	0.00% 0/126 • First day of the Treatment Period (Day 1) up to Day 72 Randomized participants who received at least 1 dose of study drug during Treatment Period (Safety Population).

Additional Information

Director, CE Studies

Teva Pharmaceuticals Inc. USA

Phone: 1-888-483-8279

Email: USMedInfo@tevapharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
• Publication restrictions are in place

Restriction type: OTHER