Trial Outcomes & Findings for Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients (NCT NCT03022097)

NCT ID: NCT03022097

Last Updated: 2025-03-26

Results Overview

Change from baseline in 1-hour morning post-dose FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Aclidinium bromide at Week 24. Baseline was defined as the average of the two FEV1 values measure prior to the administration of the first dose of the IP at randomisation visit. If one of the two values was missing, the available one was used as baseline. If both values were missing, the screening pre-bronchodilator value was used. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1625 participants
• Primary outcome timeframe: Week 24, 1-hour morning post-dose
• Results posted on: 2025-03-26

Participant Flow

The study was conducted at 81 study centers in 5 countries China(50), India (15), Philippines (8), Taiwan (3) and Vietnam (5) between 02 February 2017 and 14 April 2022

Subjects fulfilling inclusion/exclusion criteria at the time of the Screening entered into a run-in period of 14 ± 3 days to assess their disease stability before randomization. Participants who met the inclusion and none of the exclusion were considered for enrolment into the study. All study assessments were performed as per the schedule of assessments. A total of 1625 participants (consented) and undergone washout period and 1066 were randomised to treatment.

Participant milestones

Measure	AB/FF 400/12 μg Aclidinium bromide/formoterol fumarate fixed dose combination 400/12 μg	AB 400 μg Aclidinium bromide AB 400 μg	FF 12 μg Formoterol 12 μg	Placebo Placebo
Overall Study STARTED	265	267	265	269
Overall Study Received Treatment	263	266	264	269
Overall Study Received Treatment With a Baseline FEV1	262	265	259	267
Overall Study Completed Treatment	243	247	230	230
Overall Study COMPLETED	244	248	233	235
Overall Study NOT COMPLETED	21	19	32	34

Reasons for withdrawal

Measure	AB/FF 400/12 μg Aclidinium bromide/formoterol fumarate fixed dose combination 400/12 μg	AB 400 μg Aclidinium bromide AB 400 μg	FF 12 μg Formoterol 12 μg	Placebo Placebo
Overall Study Adverse Event	3	4	1	3
Overall Study Progressive Disease	2	0	5	2
Overall Study Lack of Efficacy	0	0	3	3
Overall Study Protocol Violation	1	0	1	0
Overall Study Withdrawal by Subject	11	13	15	21
Overall Study Lost to Follow-up	0	0	1	1
Overall Study Other	4	1	6	4
Overall Study Due to COVID-19 pandemic	0	1	0	0

Baseline Characteristics

Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients

Baseline characteristics by cohort

Measure	AB/FF 400/12 μg n=263 Participants Aclidinium bromide/formoterol fumarate fixed dose combination 400/12 μg	AB 400 μg n=266 Participants Aclidinium bromide AB 400 μg	FF 12 μg n=264 Participants Formoterol 12 μg	Placebo n=269 Participants Placebo	Total n=1062 Participants Total of all reporting groups
Age, Continuous	65.3 Years STANDARD_DEVIATION 7.1 • n=5 Participants	65.4 Years STANDARD_DEVIATION 6.8 • n=7 Participants	65.4 Years STANDARD_DEVIATION 7.6 • n=5 Participants	64.9 Years STANDARD_DEVIATION 6.9 • n=4 Participants	65.2 Years STANDARD_DEVIATION 7.1 • n=21 Participants
Sex/Gender, Customized Male	256 Participants n=5 Participants	254 Participants n=7 Participants	251 Participants n=5 Participants	256 Participants n=4 Participants	1017 Participants n=21 Participants
Sex/Gender, Customized Female	7 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	13 Participants n=4 Participants	45 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	263 Participants n=5 Participants	266 Participants n=7 Participants	264 Participants n=5 Participants	269 Participants n=4 Participants	1062 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Chinese	186 Participants n=5 Participants	186 Participants n=7 Participants	187 Participants n=5 Participants	188 Participants n=4 Participants	747 Participants n=21 Participants
Race/Ethnicity, Customized Taiwanese	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	14 Participants n=21 Participants
Race/Ethnicity, Customized Vietnamese	10 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	39 Participants n=21 Participants
Race/Ethnicity, Customized Indian	35 Participants n=5 Participants	37 Participants n=7 Participants	35 Participants n=5 Participants	37 Participants n=4 Participants	144 Participants n=21 Participants
Race/Ethnicity, Customized Filipino	29 Participants n=5 Participants	30 Participants n=7 Participants	29 Participants n=5 Participants	30 Participants n=4 Participants	118 Participants n=21 Participants
Pre-bronchodilator FEV1 at screening	1.187 Litres STANDARD_DEVIATION 0.404 • n=5 Participants	1.192 Litres STANDARD_DEVIATION 0.385 • n=7 Participants	1.199 Litres STANDARD_DEVIATION 0.415 • n=5 Participants	1.212 Litres STANDARD_DEVIATION 0.383 • n=4 Participants	1.197 Litres STANDARD_DEVIATION 0.396 • n=21 Participants
Post-bronchodilator FEV1 at screening	1.356 Litres STANDARD_DEVIATION 0.420 • n=5 Participants	1.363 Litres STANDARD_DEVIATION 0.390 • n=7 Participants	1.366 Litres STANDARD_DEVIATION 0.447 • n=5 Participants	1.385 Litres STANDARD_DEVIATION 0.408 • n=4 Participants	1.367 Litres STANDARD_DEVIATION 0.416 • n=21 Participants
Baseline FEV1	1.182 Litres STANDARD_DEVIATION 0.415 • n=5 Participants	1.178 Litres STANDARD_DEVIATION 0.381 • n=7 Participants	1.169 Litres STANDARD_DEVIATION 0.413 • n=5 Participants	1.184 Litres STANDARD_DEVIATION 0.399 • n=4 Participants	1.178 Litres STANDARD_DEVIATION 0.402 • n=21 Participants
Smoking status Current smoker	84 Participants n=5 Participants	85 Participants n=7 Participants	86 Participants n=5 Participants	85 Participants n=4 Participants	340 Participants n=21 Participants
Smoking status Former smoker	179 Participants n=5 Participants	181 Participants n=7 Participants	178 Participants n=5 Participants	184 Participants n=4 Participants	722 Participants n=21 Participants
Country China	186 Participants n=5 Participants	186 Participants n=7 Participants	187 Participants n=5 Participants	188 Participants n=4 Participants	747 Participants n=21 Participants
Country Taiwan	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	14 Participants n=21 Participants
Country Vietnam	10 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	39 Participants n=21 Participants
Country India	35 Participants n=5 Participants	37 Participants n=7 Participants	35 Participants n=5 Participants	37 Participants n=4 Participants	144 Participants n=21 Participants
Country Philippines	29 Participants n=5 Participants	30 Participants n=7 Participants	29 Participants n=5 Participants	30 Participants n=4 Participants	118 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 24, 1-hour morning post-dose

Population: Intention-to-Treat (ITT) population: All randomised participants who took at least one dose of IP and have a baseline FEV1 measurement.

Change from baseline in 1-hour morning post-dose FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Aclidinium bromide at Week 24.

Baseline was defined as the average of the two FEV1 values measure prior to the administration of the first dose of the IP at randomisation visit. If one of the two values was missing, the available one was used as baseline. If both values were missing, the screening pre-bronchodilator value was used.

Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.

Outcome measures

Measure	AB/FF 400/12 μg n=262 Participants Aclidinium bromide/formoterol fumarate fixed dose combination 400/12 μg	AB 400 μg n=265 Participants Aclidinium bromide AB 400 μg	FF 12 μg n=259 Participants Formoterol 12 μg	Placebo n=267 Participants Placebo
Change From Baseline in 1-hour Morning Post Forced Expiratory Volume in 1 Second (FEV1)	0.248 Litres Standard Error 0.013	0.156 Litres Standard Error 0.013	0.138 Litres Standard Error 0.013	-0.050 Litres Standard Error 0.013

PRIMARY outcome

Timeframe: Week 24, morning pre-dose (trough)

Population: Intention-to-Treat (ITT) population: All randomised participants who took at least one dose of IP and have a baseline FEV1 measurement.

Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Formoterol fumarate 12 μg at Week 24.

Morning pre-dose (trough) FEV1 was defined as the average of the two FEV1 values at morning pre-dose of IP at Week 24. If one value was missing, the remaining was used as the trough value.

Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.

Outcome measures

Measure	AB/FF 400/12 μg n=262 Participants Aclidinium bromide/formoterol fumarate fixed dose combination 400/12 μg	AB 400 μg n=265 Participants Aclidinium bromide AB 400 μg	FF 12 μg n=259 Participants Formoterol 12 μg	Placebo n=267 Participants Placebo
Change From Baseline in Morning Pre-dose (Trough) FEV1 for Aclidinium Bromide/Formoterol Fumarate	0.081 Litres Standard Error 0.014	0.050 Litres Standard Error 0.014	-0.004 Litres Standard Error 0.014	-0.084 Litres Standard Error 0.014

PRIMARY outcome

Timeframe: Week 24, morning pre-dose (trough)

Population: Intention-to-Treat (ITT) population: All randomised participants who took at least one dose of IP and have a baseline FEV1 measurement.

Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg compared to placebo at Week 24.

Morning pre-dose (trough) FEV1 was defined as the average of the two FEV1 values at morning pre-dose of IP at Week 24. If one value was missing, the remaining was used as the trough value.

Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.

Outcome measures

Measure	AB/FF 400/12 μg n=262 Participants Aclidinium bromide/formoterol fumarate fixed dose combination 400/12 μg	AB 400 μg n=265 Participants Aclidinium bromide AB 400 μg	FF 12 μg n=259 Participants Formoterol 12 μg	Placebo n=267 Participants Placebo
Change From Baseline in Morning Pre-dose (Trough) FEV1 for Aclidinium Bromide	0.081 Litres Standard Error 0.014	0.050 Litres Standard Error 0.014	-0.004 Litres Standard Error 0.014	-0.084 Litres Standard Error 0.014

SECONDARY outcome

Timeframe: Week 24, peak

Population: Intention-to-Treat (ITT) population: All randomised participants who took at least one dose of IP and have a baseline FEV1 measurement.

Change from baseline in peak FEV1 of Aclidinium bromide 400 μg compared to placebo at week 24.

Peak FEV1 was the highest value recorded at Week 24 after morning IP intake.

Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.

Outcome measures

Measure	AB/FF 400/12 μg n=262 Participants Aclidinium bromide/formoterol fumarate fixed dose combination 400/12 μg	AB 400 μg n=265 Participants Aclidinium bromide AB 400 μg	FF 12 μg n=259 Participants Formoterol 12 μg	Placebo n=267 Participants Placebo
Change From Baseline in Peak FEV1	0.324 Litres Standard Error 0.013	0.225 Litres Standard Error 0.013	0.191 Litres Standard Error 0.014	0.008 Litres Standard Error 0.014

SECONDARY outcome

Timeframe: Week 24

Population: Intention-to-Treat (ITT) population: All randomised participants who took at least one dose of IP and have a baseline FEV1 measurement.

Improvements TDI focal score of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and Aclidinium bromide 400μg compared to placebo at week 24.

Transition Dyspnoea Index (TDI) measures severity of breathlessness in symptomatic patients. An impairment severity score is assigned for three components: functional impairment; magnitude of task and magnitude of effort. Focal scores is derived as the sum of individual component scores. TDI focal score ranges from -9 to +9, with negative values indicating a worsening in dyspnoea, 0 showing no change from baseline and positive values associated with a post-baseline improvement.

Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.

Outcome measures

Measure	AB/FF 400/12 μg n=262 Participants Aclidinium bromide/formoterol fumarate fixed dose combination 400/12 μg	AB 400 μg n=265 Participants Aclidinium bromide AB 400 μg	FF 12 μg n=259 Participants Formoterol 12 μg	Placebo n=267 Participants Placebo
Improvements Transition Dyspnoea Index (TDI) Focal Score	2.9 Units on a scale Standard Error 0.2	2.6 Units on a scale Standard Error 0.2	2.4 Units on a scale Standard Error 0.2	2.1 Units on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: Week 24

Population: Intention-to-Treat (ITT) population: All randomised participants who took at least one dose of IP and have a baseline FEV1 measurement.

Change from baseline in SGRQ total score of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and Aclidinium bromide 400μg compared to placebo at week 24.

St. George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life and perceived well-being. It is composed of 50 items split into 17 parts, from which 3 dimension scores on Symptoms, Activity and Impact are derived. A total score utilising responses to all items can also be derived to assess the overall impact of COPD on quality of life. SGRQ dimension and total scores range from 0 to 100, with higher scores indicating a worse possible health status.

Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.

Outcome measures

Measure	AB/FF 400/12 μg n=262 Participants Aclidinium bromide/formoterol fumarate fixed dose combination 400/12 μg	AB 400 μg n=265 Participants Aclidinium bromide AB 400 μg	FF 12 μg n=259 Participants Formoterol 12 μg	Placebo n=267 Participants Placebo
Change From Baseline in St Georges Respiratory Questionnaire (SGRQ) Total Score	-8.7 Units on a scale Standard Error 1.2	-7.6 Units on a scale Standard Error 1.2	-7.2 Units on a scale Standard Error 1.2	-4.7 Units on a scale Standard Error 1.2

Adverse Events

AB/FF 400/12 μg

Serious events: 19 serious events

Other events: 53 other events

Deaths: 0 deaths

AB 400 μg

Serious events: 21 serious events

Other events: 44 other events

Deaths: 0 deaths

FF 12 μg

Serious events: 26 serious events

Other events: 54 other events

Deaths: 1 deaths

Placebo

Serious events: 21 serious events

Other events: 55 other events

Deaths: 2 deaths

Serious adverse events

Measure	AB/FF 400/12 μg n=263 participants at risk Aclidinium bromide/formoterol fumarate fixed dose combination 400/12 μg	AB 400 μg n=266 participants at risk Aclidinium bromide AB 400 μg	FF 12 μg n=264 participants at risk Formoterol 12 μg	Placebo n=269 participants at risk Placebo
Infections and infestations Bronchitis	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Cellulitis	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Cystitis	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Epididymitis	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Gastroenteritis	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/266 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Haemorrhagic fever with renal syndrome	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Herpes zoster	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Keratitis viral	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Laryngopharyngitis	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Lower respiratory tract infection	0.38% 1/263 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Pneumonia	0.76% 2/263 • Number of events 2 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	1.1% 3/266 • Number of events 3 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	1.9% 5/264 • Number of events 5 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	1.5% 4/269 • Number of events 4 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Postoperative wound infection	0.38% 1/263 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Sepsis	0.38% 1/263 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Tuberculosis	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Infections and infestations Upper respiratory tract infection	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/266 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of adrenal gland	0.38% 1/263 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of skin	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/266 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.38% 1/263 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/266 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/266 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Nervous system disorders Basal ganglia haemorrhage	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/266 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Nervous system disorders Cerebral arteriosclerosis	0.38% 1/263 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Nervous system disorders Cerebral haemorrhage	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Nervous system disorders Cerebral infarction	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/266 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Nervous system disorders Cluster headache	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/266 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Nervous system disorders Spondylitic myelopathy	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/266 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Nervous system disorders Transient ischaemic attack	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Eye disorders Cataract	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Eye disorders Iridocyclitis	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Ear and labyrinth disorders Vertigo	0.38% 1/263 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Cardiac disorders Acute coronary syndrome	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/266 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Cardiac disorders Acute myocardial infarction	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.76% 2/264 • Number of events 2 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Cardiac disorders Angina unstable	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Cardiac disorders Cardiac failure congestive	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Cardiac disorders Coronary artery disease	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Cardiac disorders Myocardial infarction	0.38% 1/263 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Cardiac disorders Myocardial ischaemia	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.4% 9/263 • Number of events 10 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	2.3% 6/266 • Number of events 6 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	3.8% 10/264 • Number of events 10 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	2.6% 7/269 • Number of events 7 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Gastrointestinal disorders Gastric polyps	0.38% 1/263 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Gastrointestinal disorders Gastritis erosive	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Gastrointestinal disorders Inguinal hernia	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Gastrointestinal disorders Large intestine polyp	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/266 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.38% 1/263 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.75% 2/266 • Number of events 2 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Renal and urinary disorders Acute kidney injury	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Renal and urinary disorders Chronic kidney disease	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
General disorders Death	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.37% 1/269 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Injury, poisoning and procedural complications Foot fracture	0.38% 1/263 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/266 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/264 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/263 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.38% 1/266 • Number of events 1 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/264 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	0.00% 0/269 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.

Other adverse events

Measure	AB/FF 400/12 μg n=263 participants at risk Aclidinium bromide/formoterol fumarate fixed dose combination 400/12 μg	AB 400 μg n=266 participants at risk Aclidinium bromide AB 400 μg	FF 12 μg n=264 participants at risk Formoterol 12 μg	Placebo n=269 participants at risk Placebo
Infections and infestations Upper respiratory tract infection	11.8% 31/263 • Number of events 32 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	9.4% 25/266 • Number of events 28 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	9.1% 24/264 • Number of events 27 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	8.9% 24/269 • Number of events 28 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	9.5% 25/263 • Number of events 33 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	7.9% 21/266 • Number of events 28 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	12.5% 33/264 • Number of events 44 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.	13.0% 35/269 • Number of events 43 • From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below. An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomised patients who took at least one dose of IP.

Additional Information

Global Clinical Head

AstraZeneca

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

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