Trial Outcomes & Findings for Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis (NCT NCT03920293)

NCT ID: NCT03920293

Last Updated: 2024-05-28

Results Overview

The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Estimates were based on Mixed Effect Repeated Measures (MMRM) that included treatment group, stratification factor region, and MG-ADL total score at baseline, study visit, and study visit by treatment group interaction.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 175 participants
• Primary outcome timeframe: Baseline, Week 26
• Results posted on: 2024-05-28

Participant Flow

Participants were randomized 1:1 to either the ravulizumab or placebo group during the Randomized-Controlled Period. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.

Participant milestones

Measure	Ravulizumab to Ravulizumab Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.	Placebo to Ravulizumab Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
Randomized-Controlled Period STARTED	86	89
Randomized-Controlled Period Received at Least 1 Dose of Study Drug	86	89
Randomized-Controlled Period COMPLETED	79	83
Randomized-Controlled Period NOT COMPLETED	7	6
Open- Label Extension Period STARTED	78	83
Open- Label Extension Period COMPLETED	60	63
Open- Label Extension Period NOT COMPLETED	18	20

Reasons for withdrawal

Measure	Ravulizumab to Ravulizumab Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.	Placebo to Ravulizumab Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
Randomized-Controlled Period Withdrawal by Subject	2	1
Randomized-Controlled Period Physician Decision	1	2
Randomized-Controlled Period Adverse Event	0	2
Randomized-Controlled Period Sponsor Decision	0	1
Randomized-Controlled Period Death	2	0
Randomized-Controlled Period Protocol Violation	1	0
Randomized-Controlled Period Noncompliance	1	0
Open- Label Extension Period Participants who transitioned to alternative treatment by the Investigator when the study closed	3	5
Open- Label Extension Period Death	3	3
Open- Label Extension Period Physician Decision	5	3
Open- Label Extension Period Withdrawal by Subject	7	9

Baseline Characteristics

Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis

Baseline characteristics by cohort

Measure	Ravulizumab n=86 Participants Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.	Placebo n=89 Participants Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.	Total n=175 Participants Total of all reporting groups
Age, Continuous	58.0 years STANDARD_DEVIATION 13.82 • n=5 Participants	53.3 years STANDARD_DEVIATION 16.05 • n=7 Participants	55.6 years STANDARD_DEVIATION 15.14 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	45 Participants n=7 Participants	89 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	44 Participants n=7 Participants	86 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	79 Participants n=5 Participants	78 Participants n=7 Participants	157 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized White	67 Participants n=5 Participants	61 Participants n=7 Participants	128 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 26

Population: Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Estimates were based on Mixed Effect Repeated Measures (MMRM) that included treatment group, stratification factor region, and MG-ADL total score at baseline, study visit, and study visit by treatment group interaction.

Outcome measures

Measure	Ravulizumab n=86 Participants Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.	Placebo n=89 Participants Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26	-3.1 units on a scale Standard Error 0.38	-1.4 units on a scale Standard Error 0.37

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

The QMG scoring system consisted of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0 to 39. The QMG scoring system was considered to be an objective evaluation of therapy for MG and was based on quantitative testing of sentinel muscle groups. A decrease in score indicated improvement. Estimates were based on MMRM that included treatment group, stratification factor region, and QMG total score at baseline, study visit, and study visit by treatment group interaction.

Outcome measures

Measure	Ravulizumab n=86 Participants Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.	Placebo n=89 Participants Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26	-2.8 units on a scale Standard Error 0.46	-0.8 units on a scale Standard Error 0.45

SECONDARY outcome

Timeframe: Week 26

Population: Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

The QMG scoring system consisted of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0 to 39. A decrease in score indicated improvement. Percentage of participants with a ≥5-point reduction in the QMG total score are reported. Estimates were based on a generalized linear mixed model (GLMM) that included treatment group, stratification factor region and QMG total score at baseline, study visit and study visit by treatment group interaction.

Outcome measures

Measure	Ravulizumab n=86 Participants Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.	Placebo n=89 Participants Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
Percentage of Participants With a Quantitative Myasthenia Gravis (QMG) Total Score Reduction of at Least 5 Points At Week 26	30.0 percentage of participants Interval 19.2 to 43.5	11.3 percentage of participants Interval 5.6 to 21.5

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

The revised Myasthenia Gravis Qualify of Life 15-item scale (MG-QOL15r) is a health-related QoL evaluative instrument specific to participants with MG. The MG-QOL15r was designed to provide information about participants' perception of impairment and disability, determine the degree to which disease manifestations are tolerated, and to be administered and interpreted easily. Each item was graded on a scale of 0 to 2, with 2 being the most severe. The range of MG-QOL15r score is 0 to 30. Higher scores indicated greater extent of and dissatisfaction with MG-related dysfunction. Estimates are based on MMRM that included treatment group, stratification factor region and MG-QOL15r score at baseline, study visit and study visit by treatment group interaction.

Outcome measures

Measure	Ravulizumab n=86 Participants Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.	Placebo n=89 Participants Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26	-3.3 score on a scale Standard Error 0.71	-1.6 score on a scale Standard Error 0.70

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

The Neuro-QOL Fatigue is a reliable and validated brief 19-item survey of fatigue, completed by the participant. Each items was rated on a scale of 1 to 5, with 5 being the most severe. The range of total score is 19 to 95. Higher scores indicated greater fatigue and greater impact of MG on activities. Estimates were based on MMRM that included treatment group, stratification factor region and Neuro-QoL Fatigue score at baseline, study visit, and study visit by treatment group interaction.

Outcome measures

Measure	Ravulizumab n=86 Participants Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.	Placebo n=89 Participants Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26	-7.0 units on a scale Standard Error 1.92	-4.8 units on a scale Standard Error 1.87

SECONDARY outcome

Timeframe: Week 26

Population: Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Percentage of participants with a ≥3-point reduction in the MG-ADL total score are reported. Estimates were based on a GLMM that included treatment group, stratification factor region and MG-ADL total score at baseline, study visit and study visit by treatment group interaction.

Outcome measures

Measure	Ravulizumab n=86 Participants Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.	Placebo n=89 Participants Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
Percentage of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction of at Least 3 Points At Week 26	56.7 percentage of participants Interval 44.3 to 68.3	34.1 percentage of participants Interval 23.8 to 46.1

Adverse Events

Randomized-Controlled Period: Ravulizumab

Serious events: 20 serious events

Other events: 77 other events

Deaths: 2 deaths

Randomized-Controlled Period: Placebo

Serious events: 14 serious events

Other events: 75 other events

Deaths: 0 deaths

Open-Label Extension Period: Placebo to Ravulizumab

Serious events: 32 serious events

Other events: 79 other events

Deaths: 3 deaths

Open-Label Extension Period: Ravulizumab to Ravulizumab

Serious events: 24 serious events

Other events: 77 other events

Deaths: 3 deaths

Serious adverse events

Measure	Randomized-Controlled Period: Ravulizumab n=86 participants at risk Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study.	Randomized-Controlled Period: Placebo n=89 participants at risk Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study.	Open-Label Extension Period: Placebo to Ravulizumab n=83 participants at risk After the randomized-controlled part of the study, participants in the placebo group were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.	Open-Label Extension Period: Ravulizumab to Ravulizumab n=78 participants at risk After the randomized-controlled part of the study, participants in the ravulizumab group were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
Infections and infestations COVID-19 pneumonia	2.3% 2/86 • Number of events 3 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	2.4% 2/83 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Arthritis bacterial	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Diverticulitis	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Gangrene	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Gastroenteritis viral	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Herpes zoster	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.1% 1/89 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Infected skin ulcer	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Pneumonia respiratory syncytial viral	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Staphylococcal sepsis	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations COVID-19	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.1% 1/89 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	2.4% 2/83 • Number of events 4 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	5.1% 4/78 • Number of events 6 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Cellulitis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	2.2% 2/89 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	2.4% 2/83 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Nervous system disorders Transient ischaemic attack	2.3% 2/86 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Nervous system disorders Cerebral haemorrhage	1.2% 1/86 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Nervous system disorders Myasthenia gravis crisis	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Nervous system disorders Syncope	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Nervous system disorders Facial paresis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.1% 1/89 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Nervous system disorders Myasthenia gravis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	3.4% 3/89 • Number of events 3 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	5.1% 4/78 • Number of events 4 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Nervous system disorders Trigeminal neuralgia	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.1% 1/89 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Nodal osteoarthritis	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Tendonitis	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.1% 1/89 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Respiratory, thoracic and mediastinal disorders Lung infiltration	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Dysphagia	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Nausea	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Enteritis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.1% 1/89 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
General disorders Asthenia	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
General disorders General physical health deterioration	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
General disorders Non-cardiac chest pain	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteral neoplasm	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Cardiac disorders Congestive cardiomyopathy	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Eye disorders Visual impairment	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Injury, poisoning and procedural complications Multiple fractures	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Injury, poisoning and procedural complications Infusion-related reaction	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.1% 1/89 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Metabolism and nutrition disorders Steroid diabetes	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.1% 1/89 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Psychiatric disorders Suicide attempt	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.1% 1/89 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Renal and urinary disorders Renal failure	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.1% 1/89 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Skin and subcutaneous tissue disorders Granuloma skin	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.1% 1/89 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Pneumonia	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	2.4% 2/83 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Erysipelas	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Urinary tract infection	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Anal abscess	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Appendicitis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Escherichia bacteraemia	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Gonococcal infection	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Infection	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Localised infection	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Meningitis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Neisseria infection	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Pneumonia viral	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Pyelonephritis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Sepsis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Suspected COVID-19	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Influenza	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	2.4% 2/83 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Injury, poisoning and procedural complications Fall	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Injury, poisoning and procedural complications Head injury	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Nervous system disorders Depressed level of consciousness	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Nervous system disorders Dysarthria	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Nervous system disorders Headache	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Nervous system disorders Intercostal neuralgia	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Cardiac disorders Cardiac failure congestive	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Cardiac disorders Acute myocardial infarction	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Cardiac disorders Angina pectoris	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Cardiac disorders Angina unstable	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Cardiac disorders Coronary artery disease	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Cardiac disorders Coronary artery occlusion	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Cardiac disorders Mitral valve stenosis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Cardiac disorders Myocardial infarction	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Cardiac disorders Prinzmetal angina	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Abdominal pain	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Gastric polyps	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Pancreatitis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
General disorders Pyrexia	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	2.4% 2/83 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
General disorders Chest pain	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
General disorders Death	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
General disorders Fatigue	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Metabolism and nutrition disorders Dehydration	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Psychiatric disorders Acute psychosis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Psychiatric disorders Anxiety	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Psychiatric disorders Depression	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Psychiatric disorders Panic attack	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic cystadenoma	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Renal and urinary disorders Nephrolithiasis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Renal and urinary disorders Acute kidney injury	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Vascular disorders Deep vein thrombosis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Vascular disorders Hypotension	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Vascular disorders Vein rupture	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Eye disorders Cataract	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Hepatobiliary disorders Cholelithiasis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Investigations SARS-CoV-2 test positive	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/83 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.

Other adverse events

Measure	Randomized-Controlled Period: Ravulizumab n=86 participants at risk Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study.	Randomized-Controlled Period: Placebo n=89 participants at risk Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study.	Open-Label Extension Period: Placebo to Ravulizumab n=83 participants at risk After the randomized-controlled part of the study, participants in the placebo group were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.	Open-Label Extension Period: Ravulizumab to Ravulizumab n=78 participants at risk After the randomized-controlled part of the study, participants in the ravulizumab group were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
Infections and infestations COVID-19	5.8% 5/86 • Number of events 5 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	3.4% 3/89 • Number of events 3 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	31.3% 26/83 • Number of events 28 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	38.5% 30/78 • Number of events 32 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Urinary tract infection	5.8% 5/86 • Number of events 7 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	4.5% 4/89 • Number of events 5 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	9.6% 8/83 • Number of events 13 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	9.0% 7/78 • Number of events 9 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Nasopharyngitis	3.5% 3/86 • Number of events 3 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	5.6% 5/89 • Number of events 7 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	13.3% 11/83 • Number of events 18 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	10.3% 8/78 • Number of events 10 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Diarrhoea	15.1% 13/86 • Number of events 14 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	12.4% 11/89 • Number of events 15 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	12.0% 10/83 • Number of events 12 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	7.7% 6/78 • Number of events 6 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Nausea	10.5% 9/86 • Number of events 12 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	10.1% 9/89 • Number of events 10 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	10.8% 9/83 • Number of events 18 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	9.0% 7/78 • Number of events 8 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Abdominal pain	5.8% 5/86 • Number of events 6 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	4.8% 4/83 • Number of events 5 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	5.1% 4/78 • Number of events 4 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Nervous system disorders Headache	18.6% 16/86 • Number of events 19 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	25.8% 23/89 • Number of events 27 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	20.5% 17/83 • Number of events 21 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	15.4% 12/78 • Number of events 19 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Nervous system disorders Dizziness	9.3% 8/86 • Number of events 9 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	3.4% 3/89 • Number of events 3 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	7.2% 6/83 • Number of events 10 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	5.1% 4/78 • Number of events 5 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
General disorders Fatigue	7.0% 6/86 • Number of events 7 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	6.7% 6/89 • Number of events 6 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	7.2% 6/83 • Number of events 7 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	9.0% 7/78 • Number of events 7 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
General disorders Pyrexia	1.2% 1/86 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	5.6% 5/89 • Number of events 6 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	6.0% 5/83 • Number of events 5 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	3.8% 3/78 • Number of events 3 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Back pain	8.1% 7/86 • Number of events 7 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	5.6% 5/89 • Number of events 5 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	12.0% 10/83 • Number of events 10 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	7.7% 6/78 • Number of events 6 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Arthralgia	7.0% 6/86 • Number of events 8 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	7.9% 7/89 • Number of events 8 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	10.8% 9/83 • Number of events 15 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	14.1% 11/78 • Number of events 14 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Upper respiratory tract infection	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	10.8% 9/83 • Number of events 9 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	2.6% 2/78 • Number of events 4 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Infections and infestations Bronchitis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	4.8% 4/83 • Number of events 4 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	5.1% 4/78 • Number of events 4 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Vomiting	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	6.0% 5/83 • Number of events 5 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.3% 1/78 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	6.0% 5/83 • Number of events 5 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/78 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	6.0% 5/83 • Number of events 5 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	5.1% 4/78 • Number of events 5 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	2.4% 2/83 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	7.7% 6/78 • Number of events 8 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	6.0% 5/83 • Number of events 5 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	2.6% 2/78 • Number of events 2 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Nervous system disorders Myasthenia gravis	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	3.6% 3/83 • Number of events 3 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	5.1% 4/78 • Number of events 6 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
General disorders Oedema peripheral	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	6.0% 5/83 • Number of events 6 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	6.4% 5/78 • Number of events 6 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Injury, poisoning and procedural complications Fall	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	12.0% 10/83 • Number of events 11 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	2.6% 2/78 • Number of events 3 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	7.2% 6/83 • Number of events 6 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	5.1% 4/78 • Number of events 4 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Skin and subcutaneous tissue disorders Rash	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	1.2% 1/83 • Number of events 1 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	5.1% 4/78 • Number of events 7 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Psychiatric disorders Depression	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	8.4% 7/83 • Number of events 8 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	5.1% 4/78 • Number of events 4 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.
Vascular disorders Hypertension	0.00% 0/86 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	0.00% 0/89 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	6.0% 5/83 • Number of events 7 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.	3.8% 3/78 • Number of events 3 • Day 1 (after dosing) up to 2 years Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.

Additional Information

Alexion Pharmaceuticals Inc.

Alexion Pharmaceuticals Inc.

Phone: +1 855-752-2356

Email: clinicaltrials@alexion.com

Results disclosure agreements

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