Trial Outcomes & Findings for A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs (NCT NCT03078478)

NCT ID: NCT03078478

Last Updated: 2022-01-11

Results Overview

Severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks) period. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1609 participants
• Primary outcome timeframe: 36 Weeks
• Results posted on: 2022-01-11

Participant Flow

The trial was conducted at 230 sites in 11 countries as follows. Number of sites that screened and randomised participants to treatment are given in parenthesis. Canada:(9/9), Denmark: (6/6), Estonia: (5/5), Germany: (11 /11), Greece: (7/7), Hungary: (9/9), Norway: (4/4), Poland: (9/9), Romania: (5/4), Serbia: (8/8), United States: (157/153).

The participants were previously treated with basal insulin once daily or twice daily ± oral anti-diabetic drugs excluding sulfonylureas/glinides. Pre-trial insulin was discontinued and the subjects continued their pre-trial oral anti-diabetic drugs (OADs).

Participant milestones

Measure	Insulin Degludec U200 Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Titration Period (16 Weeks) STARTED	805	804
Titration Period (16 Weeks) Full Analysis Set	805	804
Titration Period (16 Weeks) Safety Analysis Set	802	798
Titration Period (16 Weeks) COMPLETED	805	804
Titration Period (16 Weeks) NOT COMPLETED	0	0
Maintenance Period 1 (36 Weeks) STARTED	805	804
Maintenance Period 1 (36 Weeks) COMPLETED	758	761
Maintenance Period 1 (36 Weeks) NOT COMPLETED	47	43
Maintencance Period 2 (36 Weeks) STARTED	758	761
Maintencance Period 2 (36 Weeks) COMPLETED	733	734
Maintencance Period 2 (36 Weeks) NOT COMPLETED	25	27

Reasons for withdrawal

Measure	Insulin Degludec U200 Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Maintenance Period 1 (36 Weeks) Withdrawal by Subject	36	36
Maintenance Period 1 (36 Weeks) Lost to Follow-up	7	4
Maintenance Period 1 (36 Weeks) Death	3	3
Maintenance Period 1 (36 Weeks) Subject withdrawal reason not collected	1	0
Maintencance Period 2 (36 Weeks) Withdrawal by Subject	18	13
Maintencance Period 2 (36 Weeks) Lost to Follow-up	3	6
Maintencance Period 2 (36 Weeks) Death	4	6
Maintencance Period 2 (36 Weeks) Not reconsenting	0	2

Baseline Characteristics

A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

Baseline characteristics by cohort

Measure	Insulin Degludec U200 n=805 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=804 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Total n=1609 Participants Total of all reporting groups
Age, Continuous	62.9 Years STANDARD_DEVIATION 10 • n=5 Participants	62.8 Years STANDARD_DEVIATION 10 • n=7 Participants	62.8 Years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	333 Participants n=5 Participants	368 Participants n=7 Participants	701 Participants n=5 Participants
Sex: Female, Male Male	472 Participants n=5 Participants	436 Participants n=7 Participants	908 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	84 Participants n=5 Participants	100 Participants n=7 Participants	184 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	721 Participants n=5 Participants	704 Participants n=7 Participants	1425 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Asian	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	78 Participants n=5 Participants	65 Participants n=7 Participants	143 Participants n=5 Participants
Race (NIH/OMB) White	693 Participants n=5 Participants	699 Participants n=7 Participants	1392 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 Weeks

Population: The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.

Severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks) period. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.

Outcome measures

Measure	Insulin Degludec 200 n=742 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=741 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)	216.8 Episodes/(PYE*100)	243.9 Episodes/(PYE*100)

SECONDARY outcome

Timeframe: 88 weeks

Population: The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data.

The observed mean daily basal insulin doses was evaluated at the end of trial (88 weeks).

Outcome measures

Measure	Insulin Degludec 200 n=703 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=704 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks)	66.6 Units Standard Deviation 48.54	73.0 Units Standard Deviation 48.48

SECONDARY outcome

Timeframe: 36 weeks

Population: The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data.

Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.

Outcome measures

Measure	Insulin Degludec 200 n=742 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=741 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)	62.30 Episodes/(PYE*100)	93.75 Episodes/(PYE*100)

SECONDARY outcome

Timeframe: 36 weeks (maintenance 2)

Population: The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data.

Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for maintenance 2 period. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.

Outcome measures

Measure	Insulin Degludec 200 n=742 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=741 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)	0.98 Episodes/(PYE*100)	4.88 Episodes/(PYE*100)

SECONDARY outcome

Timeframe: Week 0, week 88

Population: The full analysis set (FAS) comprised all randomised subjects. Number Analyzed = number of participants with available data.

Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline to end of treatment period (week 88).

Outcome measures

Measure	Insulin Degludec 200 n=694 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=700 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks)	-0.54 Percentage of HbA1c Standard Deviation 0.91	-0.46 Percentage of HbA1c Standard Deviation 0.90

SECONDARY outcome

Timeframe: Week 0, week 88

Population: Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.

Change in fasting plasma glucose (FPG) was evaluated from baseline to end of treatment period (week 88).

Outcome measures

Measure	Insulin Degludec 200 n=685 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=689 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Change in Fasting Plasma Glucose (FPG) From Baseline to End of Treatment (up to 88 Weeks)	-35.50 mg/dL Standard Deviation 49.34	-25.68 mg/dL Standard Deviation 56.69

SECONDARY outcome

Timeframe: At 88 weeks

Population: Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.

Participants achieving a fasting plasma glucose value of less than or equal to 7.2 mmol/L (130 mg/dL) at end of treatment (up to 88 weeks).

Outcome measures

Measure	Insulin Degludec 200 n=701 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=700 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Percentage of Participants With FPG ≤ 7.2 mmol/L (130 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no) Yes	84.0 Percentage of participants	72.0 Percentage of participants
Percentage of Participants With FPG ≤ 7.2 mmol/L (130 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no) No	16.0 Percentage of participants	28.0 Percentage of participants

SECONDARY outcome

Timeframe: At 88 weeks

Population: Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.

Participants achieving a fasting plasma glucose value of less than or equal to 5.0 mmol/L (90 mg/dL) at end of treatment (up to 88 weeks).

Outcome measures

Measure	Insulin Degludec 200 n=701 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=700 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Percentage of Participants With FPG ≤ 5.0 mmol/L (90 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no) Yes	31.5 Percentage of participants	21.7 Percentage of participants
Percentage of Participants With FPG ≤ 5.0 mmol/L (90 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no) No	68.5 Percentage of participants	78.3 Percentage of participants

SECONDARY outcome

Timeframe: End of Treatment (up to 88 Weeks)

Population: Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.

Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks).

Outcome measures

Measure	Insulin Degludec 200 n=694 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=700 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no) Yes	35.3 Percentage of participants	30.0 Percentage of participants
Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no) No	64.7 Percentage of participants	70.0 Percentage of participants

SECONDARY outcome

Timeframe: At 88 weeks

Population: Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.

Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without nocturnal severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks).

Outcome measures

Measure	Insulin Degludec 200 n=694 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=700 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no) Yes	47.4 Percentage of participants	39.3 Percentage of participants
Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no) No	52.6 Percentage of participants	60.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 0, week 88

Population: Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.

Participants measured their pre-breakfast self-measured plasma glucose (SMPG) value until end of treatment (week 88). Mean pre-breakfast self-measured plasma glucose used for titration at baseline and end of treatment (up to 88 weeks) are presented.

Outcome measures

Measure	Insulin Degludec 200 n=805 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=804 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Change in Mean Pre-breakfast Self-measured Plasma Glucose Used for Titration From Baseline to End of Treatment (up to 88 Weeks) Baseline (week 0)	8.39 mmol/L Standard Deviation 2.73	8.41 mmol/L Standard Deviation 2.75
Change in Mean Pre-breakfast Self-measured Plasma Glucose Used for Titration From Baseline to End of Treatment (up to 88 Weeks) End of treatment (week 88)	5.46 mmol/L Standard Deviation 1.08	5.56 mmol/L Standard Deviation 1.23

SECONDARY outcome

Timeframe: 88 weeks

Population: The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.

Severe or BG confirmed symptomatic hypoglycaemia was evaluated during treatment (up to 88 weeks). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.

Outcome measures

Measure	Insulin Degludec 200 n=802 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=798 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)	137.8 Episodes/(PYE*100)	163.7 Episodes/(PYE*100)

SECONDARY outcome

Timeframe: 88 weeks

Population: The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.

Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated at the end of trial (88 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.

Outcome measures

Measure	Insulin Degludec 200 n=802 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=798 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)	36.93 Episodes/(PYE*100)	60.03 Episodes/(PYE*100)

SECONDARY outcome

Timeframe: 88 weeks

Population: The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.

Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for the total trial period (88 weeks). The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.

Outcome measures

Measure	Insulin Degludec 200 n=802 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=798 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Number of Severe Hypoglycaemic Episodes During Treatment (up to 88 Weeks)	2.06 Episodes/(PYE*100)	5.21 Episodes/(PYE*100)

SECONDARY outcome

Timeframe: 88 weeks

Population: The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.

The adverse events presented are treatment emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment. Number of adverse events expressed in rates, from randomisation to end of maintenance period 2 (up to 88 weeks) is presented. Rate = number of events divided by patient years of exposure multiplied by 100.

Outcome measures

Measure	Insulin Degludec 200 n=802 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=798 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Number of Adverse Events From Randomisation to End of Maintenance Period 2 (up to 88 Weeks)	367.32 Episodes/(PYE*100)	365.42 Episodes/(PYE*100)

SECONDARY outcome

Timeframe: Week 0, week 88

Population: The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data.

Change in body weight, measured in kilograms, from baseline (week 0) to end of treatment (week 88).

Outcome measures

Measure	Insulin Degludec 200 n=701 Participants Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	Insulin Glargine U300 n=703 Participants Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Change in Body Weight From Baseline to End of Treatment (up to 88 Weeks)	2.9 kg Standard Deviation 5.17	1.7 kg Standard Deviation 5.84

Adverse Events

IDeg U200

Serious events: 167 serious events

Other events: 496 other events

Deaths: 7 deaths

IGlar U300

Serious events: 141 serious events

Other events: 476 other events

Deaths: 9 deaths

Serious adverse events

Measure	IDeg U200 n=802 participants at risk Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	IGlar U300 n=798 participants at risk Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Gastrointestinal disorders Abdominal pain	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Surgical and medical procedures Abdominal wall operation	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Abscess limb	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Acetabulum fracture	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Acute interstitial pneumonitis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Renal and urinary disorders Acute kidney injury	0.50% 4/802 • Number of events 4 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	1.0% 8/798 • Number of events 9 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Acute left ventricular failure	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Acute myocardial infarction	0.75% 6/802 • Number of events 6 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.37% 3/802 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Psychiatric disorders Alcohol withdrawal syndrome	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Blood and lymphatic system disorders Anaemia	0.37% 3/802 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.50% 4/798 • Number of events 4 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Immune system disorders Anaphylactic reaction	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Angina pectoris	0.37% 3/802 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Angina unstable	0.75% 6/802 • Number of events 7 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.50% 4/798 • Number of events 4 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Ankle fracture	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Aortic valve stenosis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Appendicitis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Appendicitis perforated	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Arterial bypass occlusion	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Arteriosclerosis coronary artery	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
General disorders Asthenia	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Ataxia	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Atrial fibrillation	1.1% 9/802 • Number of events 9 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.63% 5/798 • Number of events 5 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Atrial flutter	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Atrial tachycardia	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Atrioventricular block second degree	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Renal and urinary disorders Bladder prolapse	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage I	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Eye disorders Blindness unilateral	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Investigations Blood lactic acid increased	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Bradycardia	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Bronchitis	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Bronchitis bacterial	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Bundle branch block left	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Bundle branch block right	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
General disorders Capsular contracture associated with breast implant	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Surgical and medical procedures Cardiac ablation	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Cardiac arrest	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Cardiac failure	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Cardiac failure acute	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Cardiac failure congestive	0.75% 6/802 • Number of events 6 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.38% 3/798 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Surgical and medical procedures Cardiac pacemaker insertion	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Cardiogenic shock	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Cardiomyopathy	0.25% 2/802 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Carotid artery disease	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Carotid artery occlusion	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Carotid artery stenosis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Cartilage injury	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Cellulitis	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.38% 3/798 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Cerebral infarction	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Cerebrovascular disorder	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Cervical radiculopathy	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
General disorders Chest discomfort	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
General disorders Chest pain	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Hepatobiliary disorders Cholecystitis	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Hepatobiliary disorders Cholelithiasis	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.50% 4/798 • Number of events 6 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Chronic tonsillitis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Hepatobiliary disorders Cirrhosis alcoholic	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Psychiatric disorders Confusional state	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Coronary artery disease	1.2% 10/802 • Number of events 10 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.63% 5/798 • Number of events 5 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Coronary artery occlusion	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Coronary artery stenosis	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Deep vein thrombosis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Metabolism and nutrition disorders Dehydration	0.37% 3/802 • Number of events 4 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Psychiatric disorders Delirium	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Psychiatric disorders Depression	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Skin and subcutaneous tissue disorders Diabetic foot	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Diabetic foot infection	0.37% 3/802 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Eye disorders Diabetic retinopathy	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Diverticulitis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.38% 3/798 • Number of events 4 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Diverticulum	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Dizziness	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Drug administered in wrong device	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Dysarthria	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Embolic stroke	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Embolism venous	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Emphysema	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Encephalopathy	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Endocarditis staphylococcal	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Enteritis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Escherichia urinary tract infection	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Eye disorders Eye haematoma	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Faecaloma	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Fall	0.37% 3/802 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.38% 3/798 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
General disorders Gait disturbance	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Gangrene	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Surgical and medical procedures Gastric bypass	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Gastritis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Gastritis erosive	0.37% 3/802 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Gastroenteritis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Gastroenteritis viral	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Surgical and medical procedures Gastroenterostomy	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.12% 1/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Gastrointestinal procedural complication	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Endocrine disorders Goitre	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Haematemesis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Haematochezia	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Haematoma	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Investigations Haemoglobin decreased	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Haemorrhagic stroke	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Headache	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Helicobacter infection	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Hepatitis A	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Hepatitis C	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Hiatus hernia	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Metabolism and nutrition disorders Hyperammonaemia	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Hypertension	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Hypertensive crisis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Hypertensive emergency	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Hypertensive heart disease	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Hypoaesthesia	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Metabolism and nutrition disorders Hypoglycaemia	1.00% 8/802 • Number of events 8 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	2.4% 19/798 • Number of events 21 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Hypoglycaemic coma	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Hypoglycaemic unconsciousness	0.37% 3/802 • Number of events 4 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	1.1% 9/798 • Number of events 11 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Metabolism and nutrition disorders Hyponatraemia	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Hypotonia	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Ileus	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Incision site haemorrhage	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Influenza	0.37% 3/802 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Intentional product misuse	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Internal haemorrhage	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Surgical and medical procedures Intervertebral disc operation	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Intestinal obstruction	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Intracardiac thrombus	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Blood and lymphatic system disorders Iron deficiency anaemia	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Ischaemic stroke	0.62% 5/802 • Number of events 5 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.50% 4/798 • Number of events 4 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Joint abscess	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Joint dislocation	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Joint injury	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Lacunar stroke	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Surgical and medical procedures Large intestinal polypectomy	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Ligament rupture	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Investigations Lipase increased	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Localised infection	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Loss of consciousness	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Lumbar radiculopathy	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Lyme disease	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Eye disorders Macular degeneration	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.12% 1/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage IV	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Surgical and medical procedures Medical device removal	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Metabolic encephalopathy	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Surgical and medical procedures Metabolic surgery	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Surgical and medical procedures Multiple drug therapy	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
General disorders Multiple organ dysfunction syndrome	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Myocardial infarction	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.50% 4/798 • Number of events 4 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Myocardial ischaemia	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Renal and urinary disorders Nephrolithiasis	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
General disorders Non-cardiac chest pain	0.37% 3/802 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma stage 0	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Orthostatic hypotension	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.63% 5/798 • Number of events 5 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Osteomyelitis	0.25% 2/802 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Osteomyelitis acute	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Osteopenia	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Otitis externa	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Otitis media	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma stage IV	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Pancreatic cyst	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Pancreatic duct dilatation	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Pancreatitis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Pancreatitis necrotising	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Parametritis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Peptic ulcer perforation	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Peripheral arterial occlusive disease	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Peripheral artery occlusion	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Peripheral artery stenosis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Peripheral artery thrombosis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Peripheral vascular disorder	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Peripheral venous disease	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Peritonitis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.12% 1/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Pneumonia	0.75% 6/802 • Number of events 8 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	1.1% 9/798 • Number of events 9 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Pneumonia fungal	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Renal and urinary disorders Polyuria	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Post procedural cellulitis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Post procedural infection	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Post procedural oedema	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Post procedural pulmonary embolism	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Postoperative respiratory failure	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Postoperative wound infection	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Presyncope	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Procedural hypertension	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Pyelonephritis acute	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
General disorders Pyrexia	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Radiation oesophagitis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer stage I	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Surgical and medical procedures Rehabilitation therapy	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Renal and urinary disorders Renal failure	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Renal and urinary disorders Renal mass	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Eye disorders Retinal detachment	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Eye disorders Retinal tear	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Eye disorders Retinopathy proliferative	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Eye disorders Rhegmatogenous retinal detachment	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Road traffic accident	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Immune system disorders Sarcoidosis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Sciatica	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Seizure	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Sepsis	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Sinus bradycardia	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Sinus node dysfunction	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Sinus polyp	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Sinus tachycardia	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Skin and subcutaneous tissue disorders Skin ulcer	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Small intestinal obstruction	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Staphylococcal sepsis	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Steal syndrome	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Streptococcal sepsis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
General disorders Sudden death	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Psychiatric disorders Suicidal ideation	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Syncope	0.37% 3/802 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Thrombophlebitis superficial	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Endocrine disorders Thyroid mass	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.25% 2/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Tooth abscess	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Toxicity to various agents	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Transient ischaemic attack	0.37% 3/802 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.63% 5/798 • Number of events 5 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Tuberculosis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Urinary tract infection	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.63% 5/798 • Number of events 5 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Urosepsis	0.25% 2/802 • Number of events 2 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Vascular disorders Varicose vein	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Injury, poisoning and procedural complications Vascular graft thrombosis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Cardiac disorders Ventricular hypokinesia	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Ear and labyrinth disorders Vertigo	0.37% 3/802 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Ear and labyrinth disorders Vertigo positional	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Vestibular neuronitis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Viral infection	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Viral pharyngitis	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Congenital, familial and genetic disorders Vitello-intestinal duct remnant	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Eye disorders Vitreous adhesions	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Eye disorders Vitreous haemorrhage	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Volvulus	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Investigations Weight decreased	0.00% 0/802 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.13% 1/798 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Wound infection	0.12% 1/802 • Number of events 1 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Wound infection staphylococcal	0.12% 1/802 • Number of events 3 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	0.00% 0/798 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.

Other adverse events

Measure	IDeg U200 n=802 participants at risk Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	IGlar U300 n=798 participants at risk Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
Musculoskeletal and connective tissue disorders Arthralgia	6.4% 51/802 • Number of events 59 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	8.1% 65/798 • Number of events 84 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Back pain	7.4% 59/802 • Number of events 73 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	7.8% 62/798 • Number of events 70 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Bronchitis	6.0% 48/802 • Number of events 54 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	5.8% 46/798 • Number of events 46 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Respiratory, thoracic and mediastinal disorders Cough	6.0% 48/802 • Number of events 60 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	5.8% 46/798 • Number of events 53 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Diarrhoea	9.0% 72/802 • Number of events 90 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	9.9% 79/798 • Number of events 97 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Nervous system disorders Headache	6.4% 51/802 • Number of events 61 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	7.8% 62/798 • Number of events 70 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Influenza	7.4% 59/802 • Number of events 64 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	5.1% 41/798 • Number of events 44 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Nasopharyngitis	19.0% 152/802 • Number of events 253 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	20.2% 161/798 • Number of events 265 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Nausea	5.4% 43/802 • Number of events 53 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	6.3% 50/798 • Number of events 56 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 45/802 • Number of events 49 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	5.4% 43/798 • Number of events 49 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Sinusitis	5.6% 45/802 • Number of events 58 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	5.0% 40/798 • Number of events 53 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Upper respiratory tract infection	18.1% 145/802 • Number of events 199 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	15.3% 122/798 • Number of events 177 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Infections and infestations Urinary tract infection	6.1% 49/802 • Number of events 58 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	5.9% 47/798 • Number of events 65 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.
Gastrointestinal disorders Vomiting	3.2% 26/802 • Number of events 30 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.	5.0% 40/798 • Number of events 52 • From the first trial-related activity after the subject had signed the informed consent until the End of Trial (week 88) + 7 days follow-up period. Results are based on the safety analysis set (SAS), which comprised all participants who received at least one dose of trial product. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment.

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: clinicaltrials@novonordisk.com

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.
• Publication restrictions are in place

Restriction type: OTHER