Trial Outcomes & Findings for A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors (NCT NCT03196297)

NCT ID: NCT03196297

Last Updated: 2021-11-16

Results Overview

The number of bleeding episodes that were treated during at least 24 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: During at least 24 weeks from treatment onset
• Results posted on: 2021-11-16

Participant Flow

The trial was conducted at 26 sites in 11 countries as follows: France (3), Germany (2), Italy (1), Japan (3), Spain (3), Sweden (2), Thailand (1), Turkey (3), the United Kingdom (4), Ukraine (1) and the United States (3). In addition to these sites, 5 sites were approved by the IRB/IEC and/or local health authority but did not screen or assign any participants to treatment.

The trial consisted of two treatment periods: main part which lasted at least 24 weeks for all participants in the trial and an extension part which was up to 102 weeks.

Participant milestones

Measure	Concizumab Participants received subcutaneous (s.c.) injection of concizumab once daily for up to 126 weeks (at least 24 weeks main part + 52-102 weeks extension part). The initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Participants continued the extension phase at the same dose of concizumab once daily they have reached at the end of main part for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes.
Main Period STARTED	36
Main Period Full Analysis Set (FAS)	36
Main Period Subject Analysis Set (SAS)	36
Main Period COMPLETED	32
Main Period NOT COMPLETED	4
Extension Period STARTED	32
Extension Period FAS	32
Extension Period SAS	32
Extension Period COMPLETED	29
Extension Period NOT COMPLETED	3

Reasons for withdrawal

Measure	Concizumab Participants received subcutaneous (s.c.) injection of concizumab once daily for up to 126 weeks (at least 24 weeks main part + 52-102 weeks extension part). The initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Participants continued the extension phase at the same dose of concizumab once daily they have reached at the end of main part for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes.
Main Period Withdrawal by Subject	4
Extension Period Withdrawal by Subject	1
Extension Period Lack of Efficacy	2

Baseline Characteristics

A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

Baseline characteristics by cohort

Measure	Concizumab n=36 Participants Participants were to receive subcutaneous (s.c.) injection of concizumab once daily for up to 126 weeks (24 weeks main part + 52-102 weeks extension part). The initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Participants continued the extension phase at the same dose of concizumab once daily they have reached at the end of main part for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Age, Continuous	36.9 Years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	8 Participants n=5 Participants
Race/Ethnicity, Customized White	24 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Not applicable	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: During at least 24 weeks from treatment onset

Population: The FAS included all participants who took al least one dose of the study drug.

The number of bleeding episodes that were treated during at least 24 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=21 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=8 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
The Number of Bleeding Episodes During at Least 24 Weeks From Treatment Onset	43 Episodes	13 Episodes	14 Episodes

SECONDARY outcome

Timeframe: During at least 76 weeks from treatment onset

Population: The FAS included all participants who took al least one dose of the study drug.

The number of bleeding episodes that were treated during at least 76 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=15 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=10 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=10 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
The Number of Bleeding Episodes During at Least 76 Weeks From Treatment Onset	67 Episodes	42 Episodes	123 Episodes

SECONDARY outcome

Timeframe: During at least 24 weeks from treatment onset

Population: The FAS included all participants who took al least one dose of the study drug.

Bleeds that were not linked to a specific, known action or event are called spontaneous bleeding episodes. The number of spontaneous bleeding episodes that were treated during at least 24 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=21 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=8 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
The Number of Spontaneous Bleeding Episodes During at Least 24 Weeks From Treatment Onset	16 Episodes	8 Episodes	2 Episodes

SECONDARY outcome

Timeframe: During at least 76 weeks from treatment onset

Population: The FAS included all participants who took al least one dose of the study drug.

Bleeds that were not linked to a specific, known action or event are called spontaneous bleeding episodes. The number of spontaneous bleeding episodes that were treated during at least 76 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=15 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=10 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=10 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
The Number of Spontaneous Bleeding Episodes During at Least 76 Weeks From Treatment Onset	39 Episodes	15 Episodes	29 Episodes

SECONDARY outcome

Timeframe: During at least 24 weeks from treatment onset (week 0)

Population: The SAS included all participants who took al least one dose of the study drug.

An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred during at least 24 weeks from treatment onset (week 0) are presented. The data is presented per dose level participants were on at the time of onset of the adverse event.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=36 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=15 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=8 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 24 Weeks From Treatment Onset	105 Events	16 Events	9 Events

SECONDARY outcome

Timeframe: During at least 76 weeks from treatment onset (week 0)

Population: The SAS included all participants who took al least one dose of the study drug.

An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred during at least 76 weeks from treatment onset (week 0) are presented. The data is presented per dose level participants were on at the time of onset of the adverse event.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=36 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=21 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=11 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 76 Weeks From Treatment Onset	201 Events	53 Events	44 Events

SECONDARY outcome

Timeframe: During at least 24 weeks from treatment onset (week 0)

Population: The FAS included all participants who took al least one dose of the study drug.

Occurrence of anti-concizumab antibodies during at least 24 weeks from treatment onset (week 0) is presented. In the reported data, 'Yes' infers number of participants who showed positive anti-concizumab antibody tests whereas 'No' infers number of participants who showed negative anti-concizumab antibody tests.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=36 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Occurrence of Anti-concizumab Antibodies During at Least 24 Weeks From Treatment Onset Yes	3 Participants	—	—
Occurrence of Anti-concizumab Antibodies During at Least 24 Weeks From Treatment Onset No	33 Participants	—	—

SECONDARY outcome

Timeframe: During at least 76 weeks from treatment onset (week 0)

Population: The FAS included all participants who took al least one dose of the study drug.

Occurrence of anti-concizumab antibodies during at least 76 weeks from treatment onset (week 0) is presented. In the reported data, 'Yes' infers number of participants who showed positive anti-concizumab antibody tests whereas 'No' infers number of participants who showed negative anti-concizumab antibody tests.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=36 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Occurrence of Anti-concizumab Antibodies During at Least 76 Weeks From Treatment Onset Yes	9 Participants	—	—
Occurrence of Anti-concizumab Antibodies During at Least 76 Weeks From Treatment Onset No	27 Participants	—	—

SECONDARY outcome

Timeframe: During 24 weeks from treatment onset (week 0)

Population: The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Change in fibrinogen during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=19 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=8 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Change in Fibrinogen During 24 Weeks From Treatment Onset	-0.08 gram per litre (g/L) Standard Deviation 0.61	-0.19 gram per litre (g/L) Standard Deviation 0.47	-0.27 gram per litre (g/L) Standard Deviation 0.29

SECONDARY outcome

Timeframe: During at least 76 weeks from treatment onset (week 0)

Population: The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Change in fibrinogen during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=13 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=10 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Change in Fibrinogen During at Least 76 Weeks From Treatment Onset	-0.05 gram per litre (g/L) Standard Deviation 0.39	-0.35 gram per litre (g/L) Standard Deviation 0.56	-0.23 gram per litre (g/L) Standard Deviation 0.63

SECONDARY outcome

Timeframe: During 24 weeks from treatment onset (week 0)

Population: The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Change in D-dimer during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=19 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=8 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Change in D-dimer During 24 Weeks From Treatment Onset	184.5 Nanograms per milliliter (ng/mL) Standard Deviation 404.5	272.9 Nanograms per milliliter (ng/mL) Standard Deviation 684.4	703.8 Nanograms per milliliter (ng/mL) Standard Deviation 693.6

SECONDARY outcome

Timeframe: During at least 76 weeks from treatment onset (week 0)

Population: The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Change in D-dimer during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=14 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=9 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Change in D-dimer During at Least 76 Weeks From Treatment Onset	265.4 Nanograms per milliliter (ng/mL) Standard Deviation 405.3	506.7 Nanograms per milliliter (ng/mL) Standard Deviation 369.9	1109.3 Nanograms per milliliter (ng/mL) Standard Deviation 818.5

SECONDARY outcome

Timeframe: During 24 weeks from treatment onset (week 0)

Population: The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Change in F1 + F2 during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=19 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=8 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Change in Prothrombin Fragment 1 + 2 (F1 + F2) During 24 Weeks From Treatment Onset	134 Picomoles per liter (pmol/L) Standard Deviation 156	257 Picomoles per liter (pmol/L) Standard Deviation 524	580 Picomoles per liter (pmol/L) Standard Deviation 741

SECONDARY outcome

Timeframe: During at least 76 weeks from treatment onset (week 0)

Population: The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Change in F1 + F2 during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=14 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=9 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Change in Prothrombin Fragment 1 + 2 (F1 + F2) During at Least 76 Weeks From Treatment Onset	128 pmol/L Standard Deviation 183	211 pmol/L Standard Deviation 207	889 pmol/L Standard Deviation 423

SECONDARY outcome

Timeframe: During 24 weeks from treatment onset (week 0)

Population: The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Change in PT during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=19 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=8 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Change in Prothrombin Time (PT) During 24 Weeks From Treatment Onset	-0.0 Seconds (sec) Standard Deviation 0.4	-0.3 Seconds (sec) Standard Deviation 0.9	0.3 Seconds (sec) Standard Deviation 0.7

SECONDARY outcome

Timeframe: During at least 76 weeks from treatment onset (week 0)

Population: The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Change in PT during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=14 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=9 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Change in Prothrombin Time (PT) During at Least 76 Weeks From Treatment Onset	0.0 sec Standard Deviation 0.4	0.8 sec Standard Deviation 2.7	0.4 sec Standard Deviation 0.4

SECONDARY outcome

Timeframe: During 24 weeks from treatment onset (week 0)

Population: The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Change in APTT during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=19 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=8 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Change in Activated Partial Thromboplastin Time (APTT) During 24 Weeks From Treatment Onset	1.5 sec Standard Deviation 10.2	3.1 sec Standard Deviation 6.1	6.5 sec Standard Deviation 6.9

SECONDARY outcome

Timeframe: During at least 76 weeks from treatment onset (week 0)

Population: The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Change in APTT during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=14 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=9 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Change in Activated Partial Thromboplastin Time (APTT) During at Least 76 Weeks From Treatment Onset	3.1 sec Standard Deviation 4.3	9.2 sec Standard Deviation 8.8	2.1 sec Standard Deviation 9.4

SECONDARY outcome

Timeframe: During 24 weeks from treatment onset (week 0)

Population: The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Change in AT during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=19 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=8 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Change in Anti-thrombin (AT) During 24 Weeks From Treatment Onset	7 Percentage point Standard Deviation 13	17 Percentage point Standard Deviation 31	7 Percentage point Standard Deviation 18

SECONDARY outcome

Timeframe: During at least 76 weeks from treatment onset (week 0)

Population: The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Change in AT after at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=14 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=9 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Change in Anti-thrombin (AT) After at Least 76 Weeks From Treatment	0 second Standard Deviation 12	11 second Standard Deviation 23	15 second Standard Deviation 25

SECONDARY outcome

Timeframe: Prior to the last dose administration at 24 weeks

Population: The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Concentration of concizumab prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=18 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=4 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=6 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Concentration of Concizumab Prior to the Last Dose Administration at 24 Weeks	195.2 ng/mL Standard Deviation 147.0	374.4 ng/mL Standard Deviation 644.0	2640.8 ng/mL Standard Deviation 4085.6

SECONDARY outcome

Timeframe: Prior to the last dose administration after at least 76 weeks

Population: The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Concentration of concizumab prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=13 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=10 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Concentration of Concizumab Prior to the Last Dose Administration After at Least 76 Weeks	195.1 ng/mL Standard Deviation 161.7	392.3 ng/mL Standard Deviation 427.9	4015.1 ng/mL Standard Deviation 2902.0

SECONDARY outcome

Timeframe: Prior to the last dose administration at 24 weeks

Population: The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Free TFPI (TFPI not bound to concizumab) concentration value prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=18 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=4 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=6 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value Prior to the Last Dose Administration at 24 Weeks	30.1 ng/mL Standard Deviation 15.6	64.4 ng/mL Standard Deviation 35.3	12.4 ng/mL Standard Deviation 2.2

SECONDARY outcome

Timeframe: Prior to the last dose administration after at least 76 weeks

Population: The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Free TFPI concentration value prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=13 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=10 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value Prior to the Last Dose Administration After at Least 76 Weeks	26.9 ng/mL Standard Deviation 17.1	36.1 ng/mL Standard Deviation 33.1	10.1 ng/mL Standard Deviation 5.7

SECONDARY outcome

Timeframe: Prior to the last dose administration at 24 weeks

Population: The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Peak thrombin generation is the maximal concentration of thrombin formed at a given point in time. Peak thrombin generation prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=18 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=4 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=5 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Peak Thrombin Generation Prior to the Last Dose Administration at 24 Weeks	88.6 Nanomoles per liter (nmol/L) Standard Deviation 34.5	67.5 Nanomoles per liter (nmol/L) Standard Deviation 35.0	83.4 Nanomoles per liter (nmol/L) Standard Deviation 10.6

SECONDARY outcome

Timeframe: Prior to the last dose administration after at least 76 weeks

Population: The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Peak thrombin generation is the maximal concentration of thrombin formed at a given point in time. Peak thrombin generation prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=13 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=10 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Peak Thrombin Generation Prior to the Last Dose Administration After at Least 76 Weeks	90.8 nmol/L Standard Deviation 45.2	99.1 nmol/L Standard Deviation 36.2	111.6 nmol/L Standard Deviation 63.5

SECONDARY outcome

Timeframe: Prior to the last dose administration at 24 weeks

Population: The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

The endogenous thrombin potential (ETP), defined as the amount of thrombin which can be generated after the in vitro activation of coagulation with tissue factor as trigger and phospholipids as platelet substitute. Endogenous thrombin potential prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=18 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=4 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=5 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Endogenous Thrombin Potential Prior to the Last Dose Administration at 24 Weeks	1229.1 Nanomolar*minute (nM*min) Standard Deviation 340.6	965.3 Nanomolar*minute (nM*min) Standard Deviation 362.0	1176.0 Nanomolar*minute (nM*min) Standard Deviation 278.8

SECONDARY outcome

Timeframe: Prior to the last dose administration after at least 76 weeks

Population: The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

The endogenous thrombin potential (ETP), defined as the amount of thrombin which can be generated after the in vitro activation of coagulation with tissue factor as trigger and phospholipids as platelet substitute. Endogenous thrombin potential prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=13 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=10 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Endogenous Thrombin Potential Prior to the Last Dose Administration After at Least 76 Weeks	1253.0 nM*min Standard Deviation 507.3	1352.6 nM*min Standard Deviation 349.5	1233.4 nM*min Standard Deviation 267.9

SECONDARY outcome

Timeframe: Prior to the last dose administration at 24 weeks

Population: The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Thrombin generation velocity index represents the effective rate of thrombin generation between lag time and time to peak. Thrombin generation velocity index prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=18 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=4 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=5 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Thrombin Generation Velocity Index Prior to the Last Dose Administration at 24 Weeks	9.3 nM/min Standard Deviation 4.8	7.0 nM/min Standard Deviation 5.0	8.2 nM/min Standard Deviation 1.6

SECONDARY outcome

Timeframe: Prior to the last dose administration after at least 76 weeks

Population: The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.

Thrombin generation velocity index represents the effective rate of thrombin generation between lag time and time to peak. Thrombin generation velocity index prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.

Outcome measures

Measure	Concizumab 0.15 mg/kg- Main Part n=13 Participants Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg- Main Part n=10 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg- Main Part n=7 Participants Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Thrombin Generation Velocity Index Prior to the Last Dose Administration After at Least 76 Weeks	10.3 Nano molar/min (nM/min) Standard Deviation 6.4	10.5 Nano molar/min (nM/min) Standard Deviation 4.8	16.0 Nano molar/min (nM/min) Standard Deviation 17.1

Adverse Events

Concizumab 0.15 mg/kg - Main Part

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Concizumab 0.20 mg/kg - Main Part

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Concizumab 0.25 mg/kg - Main Part

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Concizumab 0.15 mg/kg - Extension Part

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Concizumab 0.20 mg/kg - Extension Part

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Concizumab 0.25 mg/kg - Extension Part

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Concizumab 0.15 mg/kg - Main Part n=36 participants at risk Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg - Main Part n=15 participants at risk Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg - Main Part n=8 participants at risk Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.15 mg/kg - Extension Part n=19 participants at risk Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg - Extension Part n=14 participants at risk Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg - Extension Part n=10 participants at risk Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Infections and infestations Atypical pneumonia	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Gastrointestinal infection	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.

Other adverse events

Measure	Concizumab 0.15 mg/kg - Main Part n=36 participants at risk Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg - Main Part n=15 participants at risk Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg - Main Part n=8 participants at risk Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.15 mg/kg - Extension Part n=19 participants at risk Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.20 mg/kg - Extension Part n=14 participants at risk Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.	Concizumab 0.25 mg/kg - Extension Part n=10 participants at risk Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Investigations Basophil count increased	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Surgical and medical procedures Tooth repair	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Gastrointestinal disorders Abdominal pain	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	12.5% 1/8 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Gastrointestinal disorders Anal fistula	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Investigations Antithrombin III decreased	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Psychiatric disorders Anxiety	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Musculoskeletal and connective tissue disorders Arthralgia	2.8% 1/36 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	12.5% 1/8 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	14.3% 2/14 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	6.7% 1/15 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Investigations Aspartate aminotransferase increased	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Musculoskeletal and connective tissue disorders Back pain	11.1% 4/36 • Number of events 4 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	14.3% 2/14 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Skin and subcutaneous tissue disorders Blister	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Investigations Blood bilirubin increased	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Investigations Blood fibrinogen decreased	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Investigations C-reactive protein increased	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Gastrointestinal disorders Chronic gastritis	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.5% 2/19 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Conjunctivitis	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	12.5% 1/8 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Injury, poisoning and procedural complications Contusion	2.8% 1/36 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	6.7% 1/15 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 7 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.5% 2/19 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Renal and urinary disorders Crystalluria	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Gastrointestinal disorders Dental caries	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 4 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Product Issues Device physical property issue	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	6.7% 1/15 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Gastrointestinal disorders Diarrhoea	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
General disorders Exercise tolerance decreased	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Injury, poisoning and procedural complications Fall	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	14.3% 2/14 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Investigations Fibrin D dimer increased	8.3% 3/36 • Number of events 4 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	13.3% 2/15 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	25.0% 2/8 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	20.0% 2/10 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Fungal skin infection	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Gastrointestinal disorders Gastric polyps	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Gastroenteritis viral	2.8% 1/36 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Gastrointestinal infection	2.8% 1/36 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Gingivitis	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
General disorders Granuloma	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Musculoskeletal and connective tissue disorders Groin pain	2.8% 1/36 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	12.5% 1/8 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Renal and urinary disorders Haematuria	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Musculoskeletal and connective tissue disorders Haemophilic arthropathy	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	6.7% 1/15 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Nervous system disorders Headache	19.4% 7/36 • Number of events 7 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	6.7% 1/15 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.5% 2/19 • Number of events 3 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Investigations Hepatic enzyme increased	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Skin and subcutaneous tissue disorders Hyperkeratosis	2.8% 1/36 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Influenza	2.8% 1/36 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.5% 2/19 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
General disorders Influenza like illness	5.6% 2/36 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
General disorders Injection site bruising	13.9% 5/36 • Number of events 8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
General disorders Injection site haematoma	11.1% 4/36 • Number of events 5 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
General disorders Injection site haemorrhage	8.3% 3/36 • Number of events 6 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
General disorders Injection site induration	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	6.7% 1/15 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
General disorders Injection site pruritus	5.6% 2/36 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Laryngitis	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	6.7% 1/15 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Injury, poisoning and procedural complications Limb injury	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Gastrointestinal disorders Lip discolouration	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.8% 1/36 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Musculoskeletal and connective tissue disorders Myalgia	2.8% 1/36 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Nasopharyngitis	25.0% 9/36 • Number of events 11 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	6.7% 1/15 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	31.6% 6/19 • Number of events 8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Musculoskeletal and connective tissue disorders Neck pain	2.8% 1/36 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	6.7% 1/15 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 3 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Otitis externa	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	6.7% 1/15 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Cardiac disorders Palpitations	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Skin and subcutaneous tissue disorders Penile ulceration	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Periodontitis	2.8% 1/36 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Pharyngitis	2.8% 1/36 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Eye disorders Pinguecula	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Investigations Platelet count decreased	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	12.5% 1/8 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Nervous system disorders Presyncope	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	6.7% 1/15 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Investigations Prothrombin fragment 1.2 increased	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Investigations Prothrombin level increased	8.3% 3/36 • Number of events 4 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	13.3% 2/15 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	25.0% 2/8 • Number of events 3 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	20.0% 2/10 • Number of events 3 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Pyoderma	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
General disorders Pyrexia	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	6.7% 1/15 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	14.3% 2/14 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Skin and subcutaneous tissue disorders Rash	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Respiratory tract infection	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Eye disorders Retinal detachment	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Rhinitis	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.5% 2/19 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Injury, poisoning and procedural complications Skin injury	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Investigations Soluble fibrin monomer complex increased	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Investigations Thrombin-antithrombin III complex increased	5.6% 2/36 • Number of events 3 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Tooth abscess	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Gastrointestinal disorders Toothache	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	6.7% 1/15 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.5% 2/19 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Infections and infestations Upper respiratory tract infection	5.6% 2/36 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	14.3% 2/14 • Number of events 2 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	10.0% 1/10 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/19 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	7.1% 1/14 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Investigations Vitamin D decreased	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
Gastrointestinal disorders Vomiting	0.00% 0/36 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/15 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/8 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	5.3% 1/19 • Number of events 1 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/14 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.	0.00% 0/10 • From start of study drug administration (week 0) up to 134 weeks Results are based on the safety analysis set which included all dosed participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event. MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.

Additional Information

Clinical Transparency and Medical Writing (1452)

Novo Nordisk A/S

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Results disclosure agreements

• Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
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