Trial Outcomes & Findings for Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes (NCT NCT02461589)

Last Updated: 2019-07-31

Results Overview

Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

706 participants

Primary outcome timeframe

Week 0, week 26

Results posted on

2019-07-31

Participant Flow

The trial was conducted at 139 sites in 10 countries as follows: Austria: 3 sites; Canada: 8 sites; Czech Republic: 9 sites; Germany: 7 sites; Malaysia: 5 sites; Russian Federation: 7 sites; Serbia: 9 sites; South Africa: 7 sites; United Kingdom: 13 sites; United States: 71 sites.

Of the 706 subjects randomised in the trial, 705 were exposed to trial products and 1 randomised subject withdrew prior to exposure.

Participant milestones

Participant milestones
Measure	Semaglutide 0.05 mg/Day Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.1 mg/Day Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.2 mg/Day Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.3 mg/Day Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.3 mg/Day Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.6 mg/Day Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.2 mg/Day Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.8 mg/Day Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Placebo Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide Flexible Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
Overall Study STARTED	64	63	65	63	64	64	64	65	129	65
Overall Study Exposed	64	63	65	63	64	64	64	65	129	64
Overall Study COMPLETED	58	61	60	58	62	61	58	60	123	60
Overall Study NOT COMPLETED	6	2	5	5	2	3	6	5	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Semaglutide 0.05 mg/Day Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.1 mg/Day Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.2 mg/Day Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.3 mg/Day Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.3 mg/Day Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.6 mg/Day Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.2 mg/Day Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.8 mg/Day Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Placebo Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide Flexible Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
Overall Study Withdrawal by Subject	5	1	3	2	1	2	1	3	3	1
Overall Study Lost to Follow-up	0	0	2	3	1	1	3	1	3	1
Overall Study Death	0	0	0	0	0	0	0	1	0	0
Overall Study Unclassified	0	0	0	0	0	0	1	0	0	2
Overall Study Missing follow-up information	1	1	0	0	0	0	1	0	0	0
Overall Study Withdrawal from trial before exposure	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Semaglutide 0.05 mg/Day n=64 Participants Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.1 mg/Day n=63 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.2 mg/Day n=65 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.3 mg/Day n=63 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.3 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.6 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.2 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.8 mg/Day n=65 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Placebo n=129 Participants Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide Flexible n=64 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.	Total n=705 Participants Total of all reporting groups
Age, Continuous	57.53 years STANDARD_DEVIATION 9.8 • n=5 Participants	57.51 years STANDARD_DEVIATION 10.0 • n=7 Participants	58.37 years STANDARD_DEVIATION 9.58 • n=5 Participants	54.76 years STANDARD_DEVIATION 9.66 • n=4 Participants	57.20 years STANDARD_DEVIATION 10.78 • n=21 Participants	59.45 years STANDARD_DEVIATION 9.77 • n=8 Participants	53.73 years STANDARD_DEVIATION 11.35 • n=8 Participants	55.82 years STANDARD_DEVIATION 9.19 • n=24 Participants	57.08 years STANDARD_DEVIATION 9.25 • n=42 Participants	54.81 years STANDARD_DEVIATION 9.70 • n=42 Participants	56.67 years STANDARD_DEVIATION 9.94 • n=42 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	28 Participants n=7 Participants	22 Participants n=5 Participants	31 Participants n=4 Participants	35 Participants n=21 Participants	32 Participants n=8 Participants	30 Participants n=8 Participants	32 Participants n=24 Participants	57 Participants n=42 Participants	28 Participants n=42 Participants	326 Participants n=42 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	35 Participants n=7 Participants	43 Participants n=5 Participants	32 Participants n=4 Participants	29 Participants n=21 Participants	32 Participants n=8 Participants	34 Participants n=8 Participants	33 Participants n=24 Participants	72 Participants n=42 Participants	36 Participants n=42 Participants	379 Participants n=42 Participants
HbA1c (glycosylated haemoglobin)	7.87 percentage of HbA1c STANDARD_DEVIATION 0.71 • n=5 Participants	7.91 percentage of HbA1c STANDARD_DEVIATION 0.83 • n=7 Participants	7.96 percentage of HbA1c STANDARD_DEVIATION 0.82 • n=5 Participants	8.23 percentage of HbA1c STANDARD_DEVIATION 0.80 • n=4 Participants	8.06 percentage of HbA1c STANDARD_DEVIATION 0.86 • n=21 Participants	8.12 percentage of HbA1c STANDARD_DEVIATION 0.81 • n=8 Participants	8.14 percentage of HbA1c STANDARD_DEVIATION 0.87 • n=8 Participants	8.07 percentage of HbA1c STANDARD_DEVIATION 0.85 • n=24 Participants	8.12 percentage of HbA1c STANDARD_DEVIATION 0.87 • n=42 Participants	8.10 percentage of HbA1c STANDARD_DEVIATION 0.91 • n=42 Participants	8.06 percentage of HbA1c STANDARD_DEVIATION 0.84 • n=42 Participants
Fasting plasma glucose	9.26 mmol/L STANDARD_DEVIATION 2.60 • n=5 Participants	8.97 mmol/L STANDARD_DEVIATION 2.22 • n=7 Participants	9.20 mmol/L STANDARD_DEVIATION 2.28 • n=5 Participants	9.67 mmol/L STANDARD_DEVIATION 2.56 • n=4 Participants	9.32 mmol/L STANDARD_DEVIATION 2.54 • n=21 Participants	9.34 mmol/L STANDARD_DEVIATION 2.33 • n=8 Participants	9.91 mmol/L STANDARD_DEVIATION 2.70 • n=8 Participants	9.18 mmol/L STANDARD_DEVIATION 2.45 • n=24 Participants	9.67 mmol/L STANDARD_DEVIATION 2.98 • n=42 Participants	9.82 mmol/L STANDARD_DEVIATION 2.66 • n=42 Participants	9.45 mmol/L STANDARD_DEVIATION 2.59 • n=42 Participants
Body weight	93.44 kg STANDARD_DEVIATION 18.27 • n=5 Participants	92.40 kg STANDARD_DEVIATION 17.20 • n=7 Participants	98.07 kg STANDARD_DEVIATION 17.92 • n=5 Participants	94.82 kg STANDARD_DEVIATION 17.84 • n=4 Participants	92.25 kg STANDARD_DEVIATION 17.48 • n=21 Participants	92.68 kg STANDARD_DEVIATION 16.46 • n=8 Participants	96.67 kg STANDARD_DEVIATION 18.28 • n=8 Participants	93.40 kg STANDARD_DEVIATION 19.34 • n=24 Participants	93.98 kg STANDARD_DEVIATION 17.75 • n=42 Participants	95.29 kg STANDARD_DEVIATION 15.43 • n=42 Participants	94.28 kg STANDARD_DEVIATION 17.61 • n=42 Participants
Systolic blood pressure	133.70 mmHg STANDARD_DEVIATION 15.14 • n=5 Participants	130.97 mmHg STANDARD_DEVIATION 14.92 • n=7 Participants	131.34 mmHg STANDARD_DEVIATION 12.55 • n=5 Participants	132.08 mmHg STANDARD_DEVIATION 11.69 • n=4 Participants	134.02 mmHg STANDARD_DEVIATION 11.30 • n=21 Participants	132.41 mmHg STANDARD_DEVIATION 12.37 • n=8 Participants	134.20 mmHg STANDARD_DEVIATION 12.73 • n=8 Participants	131.02 mmHg STANDARD_DEVIATION 11.86 • n=24 Participants	132.17 mmHg STANDARD_DEVIATION 14.26 • n=42 Participants	132.70 mmHg STANDARD_DEVIATION 12.74 • n=42 Participants	132.43 mmHg STANDARD_DEVIATION 13.10 • n=42 Participants
Diastolic blood pressure	80.06 mmHg STANDARD_DEVIATION 8.90 • n=5 Participants	79.71 mmHg STANDARD_DEVIATION 8.56 • n=7 Participants	80.48 mmHg STANDARD_DEVIATION 8.87 • n=5 Participants	81.41 mmHg STANDARD_DEVIATION 8.05 • n=4 Participants	81.83 mmHg STANDARD_DEVIATION 6.98 • n=21 Participants	81.28 mmHg STANDARD_DEVIATION 6.90 • n=8 Participants	82.98 mmHg STANDARD_DEVIATION 6.94 • n=8 Participants	80.66 mmHg STANDARD_DEVIATION 7.62 • n=24 Participants	80.98 mmHg STANDARD_DEVIATION 8.00 • n=42 Participants	81.89 mmHg STANDARD_DEVIATION 8.40 • n=42 Participants	81.11 mmHg STANDARD_DEVIATION 7.96 • n=42 Participants

PRIMARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Semaglutide 0.05 mg/Day n=64 Participants Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.1 mg/Day n=63 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.2 mg/Day n=65 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.3 mg/Day n=63 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.3 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.6 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.2 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.8 mg/Day n=65 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Placebo n=129 Participants Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide Flexible n=64 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
Change in HbA1c (Glycosylated Haemoglobin)	-0.97 percentage of glycosylated haemoglobin Standard Deviation 0.85	-1.30 percentage of glycosylated haemoglobin Standard Deviation 1.03	-1.65 percentage of glycosylated haemoglobin Standard Deviation 0.79	-1.96 percentage of glycosylated haemoglobin Standard Deviation 0.95	-0.50 percentage of glycosylated haemoglobin Standard Deviation 0.93	-0.88 percentage of glycosylated haemoglobin Standard Deviation 0.90	-0.86 percentage of glycosylated haemoglobin Standard Deviation 0.92	-1.32 percentage of glycosylated haemoglobin Standard Deviation 0.78	-0.05 percentage of glycosylated haemoglobin Standard Deviation 0.90	-1.72 percentage of glycosylated haemoglobin Standard Deviation 0.97

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: Full analyses set. For "Semaglutide flexible arm", data was available only for 63 subjects.

Estimated mean change from baseline in FPG at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

Outcome measures

Outcome measures
Measure	Semaglutide 0.05 mg/Day n=64 Participants Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.1 mg/Day n=63 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.2 mg/Day n=65 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.3 mg/Day n=63 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.3 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.6 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.2 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.8 mg/Day n=65 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Placebo n=129 Participants Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide Flexible n=63 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
Change in Fasting Plasma Glucose (FPG)	-2.09 mmol/L Standard Deviation 1.96	-2.08 mmol/L Standard Deviation 2.23	-2.64 mmol/L Standard Deviation 2.07	-3.53 mmol/L Standard Deviation 2.20	-1.33 mmol/L Standard Deviation 2.06	-1.56 mmol/L Standard Deviation 1.74	-1.51 mmol/L Standard Deviation 2.41	-1.92 mmol/L Standard Deviation 2.34	-0.54 mmol/L Standard Deviation 2.45	-3.40 mmol/L Standard Deviation 2.84

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: Full analysis set

The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

Outcome measures

Outcome measures
Measure	Semaglutide 0.05 mg/Day n=64 Participants Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.1 mg/Day n=63 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.2 mg/Day n=65 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.3 mg/Day n=63 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.3 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.6 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.2 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.8 mg/Day n=65 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Placebo n=129 Participants Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide Flexible n=64 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
Body Weight Change	-2.75 kg Standard Deviation 2.82	-4.36 kg Standard Deviation 4.24	-6.70 kg Standard Deviation 4.57	-8.23 kg Standard Deviation 5.34	-1.48 kg Standard Deviation 3.06	-1.81 kg Standard Deviation 3.06	-1.78 kg Standard Deviation 3.41	-3.68 kg Standard Deviation 4.26	-1.22 kg Standard Deviation 3.42	-6.60 kg Standard Deviation 4.98

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Semaglutide 0.05 mg/Day n=64 Participants Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.1 mg/Day n=63 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.2 mg/Day n=65 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.3 mg/Day n=63 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.3 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.6 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.2 mg/Day n=64 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.8 mg/Day n=65 Participants Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Placebo n=129 Participants Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide Flexible n=64 Participants Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
Change in Systolic and Diastolic Blood Pressure Systolicblood pressure	-5.74 mmHg Standard Deviation 12.30	-2.77 mmHg Standard Deviation 13.21	-4.25 mmHg Standard Deviation 12.24	-9.85 mmHg Standard Deviation 11.58	-3.77 mmHg Standard Deviation 9.79	-3.20 mmHg Standard Deviation 10.89	-4.69 mmHg Standard Deviation 12.73	-2.99 mmHg Standard Deviation 11.94	-2.34 mmHg Standard Deviation 11.40	-6.62 mmHg Standard Deviation 14.02
Change in Systolic and Diastolic Blood Pressure Diastolic blood pressure	-0.60 mmHg Standard Deviation 8.78	0.66 mmHg Standard Deviation 8.26	-1.62 mmHg Standard Deviation 9.38	-4.02 mmHg Standard Deviation 8.56	-1.77 mmHg Standard Deviation 7.37	-1.89 mmHg Standard Deviation 8.20	-0.60 mmHg Standard Deviation 6.78	0.63 mmHg Standard Deviation 8.13	-0.61 mmHg Standard Deviation 8.50	-1.69 mmHg Standard Deviation 8.25

Adverse Events

Semaglutide 0.05 mg/Day

Serious events: 7 serious events

Other events: 31 other events

Deaths: 0 deaths

Semaglutide 0.1 mg/Day

Serious events: 3 serious events

Other events: 34 other events

Deaths: 0 deaths

Semaglutide 0.2 mg/Day

Serious events: 2 serious events

Other events: 39 other events

Deaths: 0 deaths

Semaglutide 0.3 mg/Day

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

Liraglutide 0.3 mg/Day

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Liraglutide 0.6 mg/Day

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Liraglutide 1.2 mg/Day

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

Liraglutide 1.8 mg/Day

Serious events: 7 serious events

Other events: 35 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Semaglutide Flexible

Serious events: 4 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Semaglutide 0.05 mg/Day n=64 participants at risk Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.1 mg/Day n=63 participants at risk Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.2 mg/Day n=65 participants at risk Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.3 mg/Day n=63 participants at risk Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.3 mg/Day n=64 participants at risk Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.6 mg/Day n=64 participants at risk Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.2 mg/Day n=64 participants at risk Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.8 mg/Day n=65 participants at risk Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Placebo n=129 participants at risk Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide Flexible n=64 participants at risk Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Cardiac disorders Acute myocardial infarction	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Gastrointestinal disorders Anal fistula	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Vascular disorders Arteriosclerosis	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Cardiac disorders Atrioventricular block complete	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Cardiac disorders Bundle branch block left	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Nervous system disorders Carotid artery stenosis	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Investigations Catheterisation cardiac	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Cardiac disorders Coronary artery disease	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Surgical and medical procedures Coronary revascularisation	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Investigations Cystoscopy	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Infections and infestations Diverticulitis	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Surgical and medical procedures Endarterectomy	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Gastrointestinal disorders Epiploic appendagitis	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Infections and infestations Escherichia pyelonephritis	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Infections and infestations Gastroenteritis viral	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Endocrine disorders Goitre	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Nervous system disorders Ischaemic stroke	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Cardiac disorders Myocardial infarction	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Vascular disorders Orthostatic hypotension	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Surgical and medical procedures Percutaneous coronary intervention	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Infections and infestations Pharyngitis	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Eye disorders Retinal detachment	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Nervous system disorders Seizure	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Infections and infestations Sepsis	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal meningioma benign	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Surgical and medical procedures Stent placement	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Cardiac disorders Supraventricular tachycardia	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Reproductive system and breast disorders Uterine polyp	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Surgical and medical procedures Vascular graft	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Cardiac disorders Ventricular fibrillation	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Infections and infestations Viral infection	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).

Other adverse events

Other adverse events
Measure	Semaglutide 0.05 mg/Day n=64 participants at risk Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.1 mg/Day n=63 participants at risk Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.2 mg/Day n=65 participants at risk Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide 0.3 mg/Day n=63 participants at risk Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.3 mg/Day n=64 participants at risk Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 0.6 mg/Day n=64 participants at risk Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.2 mg/Day n=64 participants at risk Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Liraglutide 1.8 mg/Day n=65 participants at risk Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Placebo n=129 participants at risk Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	Semaglutide Flexible n=64 participants at risk Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.
Gastrointestinal disorders Abdominal discomfort	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.8% 3/63 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.2% 2/63 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 5 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/65 • Number of events 13 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Gastrointestinal disorders Abdominal pain	3.1% 2/64 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.2% 2/63 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.6% 3/65 • Number of events 7 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.9% 5/63 • Number of events 6 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 7 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/65 • Number of events 5 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.3% 4/63 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.6% 3/65 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	9.4% 6/64 • Number of events 8 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Musculoskeletal and connective tissue disorders Arthralgia	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.6% 3/65 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.3% 4/63 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Musculoskeletal and connective tissue disorders Back pain	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.3% 4/63 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/65 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.2% 2/63 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/65 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 5 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Infections and infestations Bronchitis	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.2% 2/63 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/65 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Gastrointestinal disorders Constipation	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.3% 4/63 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	9.2% 6/65 • Number of events 11 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.9% 5/63 • Number of events 7 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	10.8% 7/65 • Number of events 7 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 6 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Respiratory, thoracic and mediastinal disorders Cough	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 5 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Metabolism and nutrition disorders Decreased appetite	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	11.1% 7/63 • Number of events 7 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	9.2% 6/65 • Number of events 6 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	12.7% 8/63 • Number of events 8 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.6% 3/65 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	14.1% 9/64 • Number of events 9 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Gastrointestinal disorders Diarrhoea	10.9% 7/64 • Number of events 10 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	15.9% 10/63 • Number of events 13 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	15.4% 10/65 • Number of events 15 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	25.4% 16/63 • Number of events 29 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.8% 5/64 • Number of events 5 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.8% 5/64 • Number of events 9 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.8% 5/64 • Number of events 8 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	12.3% 8/65 • Number of events 16 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	17.2% 11/64 • Number of events 22 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Nervous system disorders Dizziness	3.1% 2/64 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.3% 4/63 • Number of events 6 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/65 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.8% 3/63 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/65 • Number of events 5 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	9.4% 6/64 • Number of events 8 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Gastrointestinal disorders Dyspepsia	1.6% 1/64 • Number of events 6 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.9% 5/63 • Number of events 7 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.7% 5/65 • Number of events 8 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	9.5% 6/63 • Number of events 6 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.6% 3/65 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
General disorders Fatigue	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/65 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 5 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/65 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Gastrointestinal disorders Flatulence	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 5 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/65 • Number of events 6 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	9.4% 6/64 • Number of events 9 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.3% 4/63 • Number of events 8 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.6% 3/65 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.8% 3/63 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 5 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Nervous system disorders Headache	10.9% 7/64 • Number of events 17 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	12.7% 8/63 • Number of events 30 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/65 • Number of events 13 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	11.1% 7/63 • Number of events 11 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.8% 5/64 • Number of events 7 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 11 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	15.6% 10/64 • Number of events 16 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/65 • Number of events 8 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	10.9% 7/64 • Number of events 14 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Vascular disorders Hypertension	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.3% 4/63 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/65 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.6% 3/65 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Investigations Lipase increased	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.8% 3/63 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.6% 3/65 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.8% 3/63 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 5 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 5 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	10.8% 7/65 • Number of events 7 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.8% 5/64 • Number of events 5 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Musculoskeletal and connective tissue disorders Muscle spasms	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Infections and infestations Nasopharyngitis	10.9% 7/64 • Number of events 12 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	9.5% 6/63 • Number of events 7 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/65 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.9% 5/63 • Number of events 6 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 5 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.8% 5/64 • Number of events 7 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.7% 5/65 • Number of events 6 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	15.6% 10/64 • Number of events 11 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Gastrointestinal disorders Nausea	17.2% 11/64 • Number of events 16 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	19.0% 12/63 • Number of events 20 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	21.5% 14/65 • Number of events 22 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	25.4% 16/63 • Number of events 22 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	9.4% 6/64 • Number of events 7 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	10.9% 7/64 • Number of events 11 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	10.9% 7/64 • Number of events 11 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	20.0% 13/65 • Number of events 18 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	39.1% 25/64 • Number of events 35 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.1% 2/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.2% 2/63 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/65 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	4.7% 3/64 • Number of events 4 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Infections and infestations Sinusitis	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/63 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/63 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.8% 5/64 • Number of events 5 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/64 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Infections and infestations Upper respiratory tract infection	10.9% 7/64 • Number of events 8 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.2% 2/63 • Number of events 2 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.5% 1/65 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	11.1% 7/63 • Number of events 7 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	9.4% 6/64 • Number of events 6 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	3.1% 2/64 • Number of events 3 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.7% 5/65 • Number of events 6 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.2% 4/64 • Number of events 6 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).
Gastrointestinal disorders Vomiting	9.4% 6/64 • Number of events 10 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	6.3% 4/63 • Number of events 13 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	9.2% 6/65 • Number of events 9 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	9.5% 6/63 • Number of events 8 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	10.9% 7/64 • Number of events 10 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	1.6% 1/64 • Number of events 1 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	7.7% 5/65 • Number of events 8 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	0.00% 0/129 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).	9.4% 6/64 • Number of events 8 • From baseline up to week 33. Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation "as treated". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks).

Additional Information

Global Clinical Registry (GCR, 1452)

Novo Nordisk A/S

Email: [email protected]

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