Trial Outcomes & Findings for Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE) (NCT NCT03067441)

NCT ID: NCT03067441

Last Updated: 2021-03-01

Results Overview

TEAEs are defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) Study.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1462 participants
• Primary outcome timeframe: Up to Week 82
• Results posted on: 2021-03-01

Participant Flow

After successfully completing 52 weeks of treatment in the parent study, Study 1002-040 (NCT02666664), and meeting entry criteria, participants could enrol into this Open-label Extension (OLE) study.

Participant milestones

Measure	Placebo; Bempedoic Acid In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Overall Study STARTED	492	970
Overall Study COMPLETED	459	913
Overall Study NOT COMPLETED	33	57

Reasons for withdrawal

Measure	Placebo; Bempedoic Acid In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Overall Study Withdrawal by Subject	16	34
Overall Study Lost to Follow-up	7	5
Overall Study Adverse Event	7	14
Overall Study Study Terminated by Sponsor or Investigator	1	0
Overall Study Physician Decision	1	3
Overall Study Other	1	1

Baseline Characteristics

Only participants with non-missing data were analysed.

Baseline characteristics by cohort

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	Total n=1462 Participants Total of all reporting groups
Age, Continuous	67.5 years STANDARD_DEVIATION 8.54 • n=492 Participants	66.5 years STANDARD_DEVIATION 8.81 • n=970 Participants	66.9 years STANDARD_DEVIATION 8.73 • n=1462 Participants
Sex: Female, Male Female	142 Participants n=492 Participants	239 Participants n=970 Participants	381 Participants n=1462 Participants
Sex: Female, Male Male	350 Participants n=492 Participants	731 Participants n=970 Participants	1081 Participants n=1462 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=492 Participants	2 Participants n=970 Participants	2 Participants n=1462 Participants
Race (NIH/OMB) Asian	5 Participants n=492 Participants	9 Participants n=970 Participants	14 Participants n=1462 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=492 Participants	1 Participants n=970 Participants	1 Participants n=1462 Participants
Race (NIH/OMB) Black or African American	6 Participants n=492 Participants	23 Participants n=970 Participants	29 Participants n=1462 Participants
Race (NIH/OMB) White	480 Participants n=492 Participants	931 Participants n=970 Participants	1411 Participants n=1462 Participants
Race (NIH/OMB) More than one race	0 Participants n=492 Participants	1 Participants n=970 Participants	1 Participants n=1462 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=492 Participants	3 Participants n=970 Participants	4 Participants n=1462 Participants
Low-density lipoprotein cholesterol (LDL-C): Parent Study	98.96 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 24.171 • n=492 Participants	102.94 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 29.899 • n=970 Participants	101.60 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 28.156 • n=1462 Participants
Non-high-density lipoprotein cholesterol (N-HDL-C): Parent Study	126.41 mg/dL STANDARD_DEVIATION 28.531 • n=492 Participants	130.09 mg/dL STANDARD_DEVIATION 34.727 • n=970 Participants	128.85 mg/dL STANDARD_DEVIATION 32.809 • n=1462 Participants
Total cholesterol: Parent Study	175.33 mg/dL STANDARD_DEVIATION 30.026 • n=492 Participants	178.94 mg/dL STANDARD_DEVIATION 36.057 • n=970 Participants	177.73 mg/dL STANDARD_DEVIATION 34.179 • n=1462 Participants
Apolipoprotein B: Parent Study	85.1 mg/dL STANDARD_DEVIATION 19.25 • n=487 Participants • Only participants with non-missing data were analysed.	88.2 mg/dL STANDARD_DEVIATION 21.71 • n=969 Participants • Only participants with non-missing data were analysed.	87.2 mg/dL STANDARD_DEVIATION 20.97 • n=1456 Participants • Only participants with non-missing data were analysed.
High-sensitivity C-reactive protein (hs-CRP): Parent Study	1.515 milligrams per Liter (mg/L) n=490 Participants • Only participants with non-missing data were analysed.	1.500 milligrams per Liter (mg/L) n=969 Participants • Only participants with non-missing data were analysed.	1.510 milligrams per Liter (mg/L) n=1459 Participants • Only participants with non-missing data were analysed.
Triglycerides: Parent Study	122.00 mg/dL n=492 Participants	125.00 mg/dL n=970 Participants	124.00 mg/dL n=1462 Participants
High-density lipoprotein cholesterol (HDL-C): Parent Study	48.93 mg/dL STANDARD_DEVIATION 11.206 • n=492 Participants	48.82 mg/dL STANDARD_DEVIATION 11.790 • n=970 Participants	48.86 mg/dL STANDARD_DEVIATION 11.593 • n=1462 Participants
LDL-C: OLE Study	99.5 mg/dL STANDARD_DEVIATION 28.59 • n=492 Participants	86.6 mg/dL STANDARD_DEVIATION 30.18 • n=970 Participants	91.0 mg/dL STANDARD_DEVIATION 30.26 • n=1462 Participants
N-HDL-C: OLE Study	126.1 mg/dL STANDARD_DEVIATION 32.61 • n=492 Participants	113.7 mg/dL STANDARD_DEVIATION 34.57 • n=970 Participants	117.9 mg/dL STANDARD_DEVIATION 34.42 • n=1462 Participants
Total cholesterol: OLE Study	175.2 mg/dL STANDARD_DEVIATION 34.23 • n=492 Participants	159.8 mg/dL STANDARD_DEVIATION 36.41 • n=970 Participants	165.0 mg/dL STANDARD_DEVIATION 36.41 • n=1462 Participants
Apolipoprotein B: OLE Study	87.6 mg/dL STANDARD_DEVIATION 22.74 • n=492 Participants	80.4 mg/dL STANDARD_DEVIATION 21.31 • n=970 Participants	82.8 mg/dL STANDARD_DEVIATION 22.07 • n=1462 Participants
hs-CRP: OLE Study	1.560 mg/L n=492 Participants	1.250 mg/L n=970 Participants	1.325 mg/L n=1462 Participants
Triglycerides: OLE Study	120.0 mg/dL n=492 Participants	121.0 mg/dL n=970 Participants	120.0 mg/dL n=1462 Participants
HDL-C: OLE Study	49.0 mg/dL STANDARD_DEVIATION 11.72 • n=492 Participants	46.1 mg/dL STANDARD_DEVIATION 13.00 • n=970 Participants	47.1 mg/dL STANDARD_DEVIATION 12.66 • n=1462 Participants

PRIMARY outcome

Timeframe: Up to Week 82

Population: Safety Population: all enrolled participants who received at least 1 dose of bempedoic acid in the OLE Study

TEAEs are defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with TEAEs	385 Participants	758 Participants	1143 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with serious TEAEs	97 Participants	202 Participants	299 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with TEAEs of mild severity	93 Participants	195 Participants	288 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with TEAEs of moderate severity	211 Participants	403 Participants	614 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with TEAEs of severe severity	81 Participants	160 Participants	241 Participants

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 78

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: LDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Percent Change From Parent Study Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 52 and 78 Week 52	-12.82 percent change Standard Deviation 23.419	-13.80 percent change Standard Deviation 25.018	-13.47 percent change Standard Deviation 24.485
Percent Change From Parent Study Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 52 and 78 Week 78	-14.99 percent change Standard Deviation 23.660	-14.15 percent change Standard Deviation 25.113	-14.43 percent change Standard Deviation 24.632

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 78

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Mean change from Baseline was calculated as: Mean LDL-C value at Week 52/Week 78 minus Mean Parent Study Baseline value. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Mean Change From Parent Study Baseline in LDL-C at Weeks 52 and 78 Week 52	-14.08 milligrams per deciliter (mg/dL) Standard Deviation 24.995	-15.77 milligrams per deciliter (mg/dL) Standard Deviation 28.123	-15.19 milligrams per deciliter (mg/dL) Standard Deviation 27.109
Mean Change From Parent Study Baseline in LDL-C at Weeks 52 and 78 Week 78	-16.11 milligrams per deciliter (mg/dL) Standard Deviation 25.628	-16.04 milligrams per deciliter (mg/dL) Standard Deviation 28.929	-16.06 milligrams per deciliter (mg/dL) Standard Deviation 27.862

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 72

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: non-HDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Percent Change From Parent Study Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 52 and 78 Week 52	-10.60 percent change Standard Deviation 20.722	-10.55 percent change Standard Deviation 22.682	-10.57 percent change Standard Deviation 22.033
Percent Change From Parent Study Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 52 and 78 Week 78	-12.50 percent change Standard Deviation 22.081	-10.82 percent change Standard Deviation 23.910	-11.38 percent change Standard Deviation 23.321

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 78

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Total cholesterol value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Percent Change From Parent Study Baseline in Total Cholesterol at Weeks 52 and 78 Week 52	-9.01 percent change Standard Deviation 15.961	-9.79 percent change Standard Deviation 16.893	-9.53 percent change Standard Deviation 16.582
Percent Change From Parent Study Baseline in Total Cholesterol at Weeks 52 and 78 Week 78	-10.15 percent change Standard Deviation 16.541	-9.34 percent change Standard Deviation 18.030	-9.61 percent change Standard Deviation 17.545

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 78

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: ApoB value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Percent Change From Parent Study Baseline in Apolipoprotein B (ApoB) at Weeks 52 and 78 Week 52	-7.5 percent change Standard Deviation 20.52	-8.8 percent change Standard Deviation 21.89	-8.4 percent change Standard Deviation 21.44
Percent Change From Parent Study Baseline in Apolipoprotein B (ApoB) at Weeks 52 and 78 Week 78	-7.6 percent change Standard Deviation 22.15	-7.0 percent change Standard Deviation 22.33	-7.2 percent change Standard Deviation 22.26

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 78

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: hs-CRP value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Percent Change From Parent Study Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Weeks 52 and 78 Week 52	-11.553 percent change Interval -53.12 to 44.167	-19.709 percent change Interval -52.617 to 34.151	-16.476 percent change Interval -52.874 to 41.667
Percent Change From Parent Study Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Weeks 52 and 78 Week 78	-15.005 percent change Interval -50.51 to 44.0	-18.065 percent change Interval -51.701 to 50.505	-16.740 percent change Interval -51.577 to 48.279

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 78

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Triglycerides value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Percent Change From Parent Study Baseline in Triglycerides at Weeks 52 and 78 Week 52	-4.31 percent change Interval -24.08 to 21.75	-3.21 percent change Interval -22.76 to 23.5	-3.49 percent change Interval -23.02 to 22.4
Percent Change From Parent Study Baseline in Triglycerides at Weeks 52 and 78 Week 78	-5.00 percent change Interval -25.54 to 24.26	-2.60 percent change Interval -21.41 to 27.47	-3.08 percent change Interval -22.78 to 26.67

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 78

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: HDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Percent Change From Parent Study Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 52 and 78 Week 52	-4.54 percent change Standard Deviation 16.747	-7.06 percent change Standard Deviation 15.638	-6.20 percent change Standard Deviation 16.060
Percent Change From Parent Study Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 52 and 78 Week 78	-3.42 percent change Standard Deviation 17.555	-4.91 percent change Standard Deviation 16.731	-4.41 percent change Standard Deviation 17.018

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 78

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: LDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Percent Change From Open-Label Extension (OLE) Study Baseline in LDL-C at Weeks 52 and 78 Week 52	-12.4 percent change Standard Deviation 23.79	3.6 percent change Standard Deviation 27.49	-1.8 percent change Standard Deviation 27.35
Percent Change From Open-Label Extension (OLE) Study Baseline in LDL-C at Weeks 52 and 78 Week 78	-14.3 percent change Standard Deviation 25.79	3.7 percent change Standard Deviation 30.63	-2.3 percent change Standard Deviation 30.31

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 72

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Mean change from Baseline was calculated as: Mean LDL-C value at Week 52/Week 78 minus Mean OLE Study Baseline value. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Mean Change From OLE Baseline in LDL-C at Weeks 52 and 78 Week 52	-14.7 mg/dL Standard Deviation 25.63	0.6 mg/dL Standard Deviation 24.92	-4.6 mg/dL Standard Deviation 26.17
Mean Change From OLE Baseline in LDL-C at Weeks 52 and 78 Week 78	-17.0 mg/dL Standard Deviation 28.56	0.2 mg/dL Standard Deviation 26.04	-5.5 mg/dL Standard Deviation 28.08

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 78

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: non-HDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Percent Change From OLE Baseline in Non-HDL-C at Weeks 52 and 78 Week 52	-10.0 percent change Standard Deviation 20.81	2.9 percent change Standard Deviation 23.98	-1.4 percent change Standard Deviation 23.75
Percent Change From OLE Baseline in Non-HDL-C at Weeks 52 and 78 Week 78	-11.8 percent change Standard Deviation 23.08	3.1 percent change Standard Deviation 28.02	-1.9 percent change Standard Deviation 27.38

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 78

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Total Cholesterol value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Percent Change From OLE Baseline in Total Cholesterol at Weeks 52 and 78 Week 52	-8.7 percent change Standard Deviation 15.78	1.3 percent change Standard Deviation 17.23	-2.1 percent change Standard Deviation 17.40
Percent Change From OLE Baseline in Total Cholesterol at Weeks 52 and 78 Week 78	-9.7 percent change Standard Deviation 17.39	2.1 percent change Standard Deviation 19.88	-1.8 percent change Standard Deviation 19.88

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 78

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: ApoB value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Percent Change From OLE Baseline ApoB at Weeks 52 and 78 Week 52	-10.0 percent change Standard Deviation 19.94	0.2 percent change Standard Deviation 21.48	-3.2 percent change Standard Deviation 21.51
Percent Change From OLE Baseline ApoB at Weeks 52 and 78 Week 78	-10.2 percent change Standard Deviation 21.84	2.4 percent change Standard Deviation 23.16	-1.8 percent change Standard Deviation 23.49

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 78

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: hs-CRP value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Percent Change From OLE Baseline in Hs-CRP at Weeks 52 and 78 Week 52	-11.720 percent change Interval -50.315 to 38.433	-2.174 percent change Interval -39.583 to 61.765	-4.856 percent change Interval -43.75 to 52.8
Percent Change From OLE Baseline in Hs-CRP at Weeks 52 and 78 Week 78	-14.953 percent change Interval -50.549 to 43.333	3.774 percent change Interval -36.842 to 69.136	-2.538 percent change Interval -41.509 to 60.268

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 78

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Triglycerides value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Percent Change From OLE Baseline in Triglycerides at Weeks 52 and 78 Week 52	0.3 percent change Interval -22.4 to 23.6	0.9 percent change Interval -20.2 to 25.2	0.7 percent change Interval -20.7 to 24.3
Percent Change From OLE Baseline in Triglycerides at Weeks 52 and 78 Week 78	-2.0 percent change Interval -23.8 to 24.1	2.2 percent change Interval -19.2 to 27.2	0.9 percent change Interval -20.9 to 26.6

SECONDARY outcome

Timeframe: Baseline; Week 52 and Week 78

Population: Safety Population. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: HDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

Outcome measures

Measure	Placebo; Bempedoic Acid n=492 Participants In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 Participants In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 Participants In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Percent Change From OLE Baseline in HDL-C at Weeks 52 and 78 Week 52	-4.3 percent change Standard Deviation 18.36	-0.6 percent change Standard Deviation 14.88	-1.8 percent change Standard Deviation 16.23
Percent Change From OLE Baseline in HDL-C at Weeks 52 and 78 Week 78	-3.4 percent change Standard Deviation 17.77	2.7 percent change Standard Deviation 23.60	0.7 percent change Standard Deviation 22.01

Adverse Events

Placebo; Bempedoic Acid

Serious events: 97 serious events

Other events: 108 other events

Deaths: 3 deaths

Bempedoic Acid; Bempedoic Acid

Serious events: 202 serious events

Other events: 201 other events

Deaths: 10 deaths

OLE Bempedoic Acid

Serious events: 299 serious events

Other events: 309 other events

Deaths: 13 deaths

Serious adverse events

Measure	Placebo; Bempedoic Acid n=492 participants at risk In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 participants at risk In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 participants at risk In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Cardiac disorders Coronary artery disease	0.61% 3/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	1.5% 15/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	1.2% 18/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Angina pectoris	1.0% 5/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.93% 9/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.96% 14/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Atrial fibrillation	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	1.2% 12/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.96% 14/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Angina unstable	0.61% 3/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	1.0% 10/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.89% 13/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Acute myocardial infarction	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.72% 7/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.62% 9/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Myocardial ischaemia	0.61% 3/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.62% 6/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.62% 9/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Myocardial infarction	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.62% 6/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.55% 8/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Cardiac failure	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.52% 5/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.34% 5/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Cardiac failure congestive	0.61% 3/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.34% 5/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Coronary artery stenosis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.41% 4/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.27% 4/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Cardiac failure chronic	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.31% 3/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 3/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Ventricular tachyarrhythmia	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Ventricular tachycardia	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Pneumonia	1.2% 6/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.93% 9/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	1.0% 15/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Sepsis	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.41% 4/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.41% 6/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Cellulitis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Gastroenteritis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Influenza	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Lower respiratory tract infection	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Urinary tract infection	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Appendicitis	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Appendicitis perforated	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Arthritis infective	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Bronchitis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Cystitis	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Diverticulitis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Epididymitis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Erysipelas	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Gastrointestinal infection	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Intervertebral discitis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Lymph node tuberculosis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Meningitis viral	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Pneumonia legionella	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Pulmonary tuberculosis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Streptococcal bacteraemia	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Urosepsis	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.27% 4/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone B-cell lymphoma (MALT type)	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypergammaglobulinaemia benign monoclonal	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage III	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IV	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary renal cell carcinoma	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Carotid artery stenosis	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.62% 6/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.55% 8/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Ischaemic stroke	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.31% 3/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.34% 5/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Cerebrovascular accident	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.31% 3/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.27% 4/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Syncope	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 3/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Carotid artery occlusion	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Cerebral infarction	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Presyncope	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Toxic encephalopathy	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Transient ischaemic attack	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Cerebral haematoma	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Dysarthria	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders External compression headache	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Facial paralysis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Haemorrhage intracranial	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Intracranial aneurysm	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Unresponsive to stimuli	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.81% 4/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.62% 6/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.68% 10/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Musculoskeletal and connective tissue disorders Arthralgia	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.27% 4/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Musculoskeletal and connective tissue disorders Back pain	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.31% 3/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.27% 4/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Inguinal hernia	0.81% 4/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.34% 5/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Pancreatitis acute	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 3/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Pancreatitis	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Abdominal pain	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Gastritis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Hiatus hernia	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Large intestinal ulcer	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Large intestine polyp	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Melaena	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Peptic ulcer	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Rectal polyp	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Gastrointestinal disorders Umbilical hernia	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Vascular disorders Peripheral arterial occlusive disease	0.61% 3/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.52% 5/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.55% 8/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Vascular disorders Peripheral ischaemia	0.81% 4/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.27% 4/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Vascular disorders Aortic aneurysm	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 3/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Vascular disorders Hypertension	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Vascular disorders Peripheral vascular disorder	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Vascular disorders Angiodysplasia	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Vascular disorders Aortic stenosis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Vascular disorders Femoral artery aneurysm	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Vascular disorders Hypertensive crisis	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Vascular disorders Hypertensive emergency	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Vascular disorders Peripheral artery occlusion	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Vascular disorders Peripheral artery stenosis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Vascular disorders Temporal arteritis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
General disorders Non-cardiac chest pain	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.82% 8/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.62% 9/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
General disorders Chest pain	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.41% 4/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.34% 5/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
General disorders Death	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
General disorders Accidental death	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
General disorders Brain death	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
General disorders Chest discomfort	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
General disorders Hernia	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
General disorders Pyrexia	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
General disorders Vascular stent occlusion	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
General disorders Vascular stent thrombosis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Fall	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Femoral neck fracture	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Intestinal anastomosis complication	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Meniscus injury	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Vascular graft occlusion	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Ankle fracture	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Craniocerebral injury	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Femur fracture	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Incisional hernia	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Peripheral artery restenosis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Periprocedural myocardial infarction	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Procedural pain	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Skull fracture	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Tendon rupture	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.41% 4/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.27% 4/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.31% 3/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.27% 4/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Renal and urinary disorders Acute kidney injury	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.62% 6/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.55% 8/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Renal and urinary disorders Haematuria	0.61% 3/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.34% 5/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Renal and urinary disorders Ureterolithiasis	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Renal and urinary disorders Micturition disorder	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Renal and urinary disorders Renal failure	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Eye disorders Cataract	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.62% 6/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.48% 7/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Eye disorders Retinal artery occlusion	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Eye disorders Visual impairment	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Hepatobiliary disorders Cholelithiasis	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.31% 3/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.27% 4/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Hepatobiliary disorders Cholecystitis acute	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 2/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 3/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Hepatobiliary disorders Hepatitis acute	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Investigations Blood creatinine increased	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Investigations Blood pressure decreased	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Investigations Haemoglobin decreased	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Investigations Stress echocardiogram abnormal	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Investigations Transaminases increased	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Investigations Troponin increased	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Investigations Ultrasound ovary abnormal	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Metabolism and nutrition disorders Dehydration	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 3/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Metabolism and nutrition disorders Hyperkalaemia	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Metabolism and nutrition disorders Hypokalaemia	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Blood and lymphatic system disorders Anaemia	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.21% 3/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Blood and lymphatic system disorders Abdominal lymphadenopathy	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Blood and lymphatic system disorders Splenic haematoma	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Skin and subcutaneous tissue disorders Dermatitis contact	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Skin and subcutaneous tissue disorders Skin ulcer	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Reproductive system and breast disorders Prostatitis	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Endocrine disorders Adrenal cyst	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Endocrine disorders Hyperparathyroidism primary	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Congenital, familial and genetic disorders Multiple endocrine neoplasia Type 1	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Product Issues Device malfunction	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Acute coronary syndrome	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Acute left ventricular failure	0.41% 2/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.00% 0/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Anginal equivalent	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Atrial flutter	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Atrioventricular block complete	0.20% 1/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.14% 2/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Supraventricular tachycardia	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Cardiac failure acute	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Cardiac disorders Left ventricular dysfunction	0.00% 0/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.10% 1/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	0.07% 1/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.

Other adverse events

Measure	Placebo; Bempedoic Acid n=492 participants at risk In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP).	Bempedoic Acid; Bempedoic Acid n=970 participants at risk In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.	OLE Bempedoic Acid n=1462 participants at risk In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP.
Infections and infestations Nasopharyngitis	6.7% 33/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	8.9% 86/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	8.1% 119/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Urinary tract infection	8.1% 40/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	5.1% 49/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	6.1% 89/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Musculoskeletal and connective tissue disorders Arthralgia	6.1% 30/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	3.9% 38/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	4.7% 68/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Infections and infestations Upper respiratory tract infection	3.7% 18/492 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	5.1% 49/970 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.	4.6% 67/1462 • Up to Week 82 Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.

Additional Information

Medical Director

Esperion Therapeutics, Inc.

Phone: 1-833-377-7633

Email: medinfo@esperion.com

Results disclosure agreements

• Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. If the Principal Investigator plans to publish information from the study, a copy of the manuscript should be provided to the Sponsor for review before submission for publication or presentation. The Sponsor may request that that publication be withheld.
• Publication restrictions are in place

Restriction type: OTHER